Maryland, Virginia Resume J&J Vaccine Use
COVID-19 Cases Reach 1,142,896 in D.C., Md. and Va.
As of Saturday morning, 47,219 people have tested positive for COVID-19, the disease caused by the coronavirus, in D.C. with 1,099 deaths; there have been 442,351 cases in Maryland with 8,462 deaths; and in Virginia there have been 653,326 cases with 10,675 deaths. You can read last week’s updates here.
The Maryland and Virginia departments of health recommended that providers resume the use of the Johnson & Johnson coronavirus vaccine after the Centers for Disease Control and the Food and Drug Administration investigated reports of rare blood clots in patients that received the vaccine. The decision came after the CDC and FDA found the benefits of the one-shot vaccine outweigh its risks. “MDH believes that, while it is important to understand the risks of any medical therapy, the benefits of COVID-19 vaccines outweigh the risks,” the Maryland Department of Health department said in a press release. After a thorough safety and review, the CDC and FDA lifted a pause of the J&J vaccine on Friday and said healthcare providers should carefully resume using the vaccine for those 18 and older. “The Johnson & Johnson vaccine is one of our most important tools in the ongoing fight to prevent hospitalizations and deaths associated with COVID-19,” Dr. Jinlene Chan, MDH’s deputy secretary for public health services, said. “By resuming use of this safe and effective vaccine in Maryland, we will continue to bolster our ability to stay ahead of new cases and emerging variants.” Dr. Danny Avula, Virginia’s state vaccine coordinator, said in a press release, “This extra scrutiny should instill confidence in the system that is in place to guarantee COVID-19 vaccine safety. As with any vaccine, we encourage individuals to educate themselves on any potential side effects and to weigh that against the possibility of hospitalization or death from COVID-19.” MDH said providers should share with patients updated information about the potential risks related to the vaccine, including the rare occurrence of thrombosis with thrombocytopenia syndrome. The condition causes a rare type of blood clot found in combination with low platelet levels, the release said. Out of nearly 8 million doses of the Johnson & Johnson COVID-19 vaccine administered, 15 cases of TTS have been identified. Most such cases occurred in females ages 18-49 with the onset of symptoms one to two weeks after vaccination. Three of the patients died, according to the CDC. One woman who died was a 45-year-old Virginia resident who received the vaccine on March 6.
Maryland is seeing some of the strongest results nationally in its battle against COVID-19, and data analysis indicates that the entire DMV took a tough stand against the pandemic during the fall and winter surge. In a press release Saturday, Maryland Gov. Larry Hogan said new analysis shows the state has the lowest COVID-19 transmission rate in the country. The Centre for Mathematical Modeling of Infectious Diseases cited Maryland as the only state in the country right now in the confirmed “decreasing” category for rate of spread, currently at 0.86. The report analyzed data through April 20. Hogan said Maryland had a 43% drop in new COVID-19 cases over the past week — the biggest drop of any state in the county — and its seven-day positivity rate has fallen below 5%. The same report had D.C. and Virginia in the “likely decreasing” category with an effective reproduction numbers of 0.98 and 0.94, respectively.
The Smithsonian will reopen seven of its museums and the National Zoo in May. The schedule includes the National Air and Space Museum’s Udvar-Hazy Center on May 5; the National Museum of African American History and Culture, National Portrait Gallery, Smithsonian American Art Museum and Renwick Gallery on May 14; and the National Museum of American History, National Museum of the American Indian and National Zoo on May 21. All outdoor Smithsonian Gardens are already opened and don’t require a timed pass. The museums initially closed in December, following Mayor Muriel Bowser’s temporary order issued in the wake of rising coronavirus cases. A handful of local museums have since announced reopening plans, as vaccination rollouts continue across the region. The museums were chosen to open first because they opened last year and have already been through the process of opening with new logistical and safety measures in place. The openings are staggered over three weeks for logistical reasons, a Smithsonian spokesperson said. Free, timed passes will be required to visit the museums and zoo and can be reserved online or by calling 800-514-3849, ext. 1. Passes can be reserved up to 30 days in advance and people can book up to six passes. Groups larger than six are prohibited, and people under 18 must be accompanied by an adult. People who want to see Xiao Qi J, the zoo’s growing panda cub, viewing will be limited for social distancing purposes and will require a separate free, timed-entry pass. Passes to see the Asia Trail and the pandas will be released throughout the day, and visitors can pick them up when they arrive at the zoo. Most of the museums will only be open Wednesday through Sunday, except the American History museum wich will be open Friday through Tuesday, and will open at various times. The Udvar-Hazy Center in Chantilly and the zoo will be open daily. Masks will be required at all times, except when eating or drinking in designated areas. Social distancing, hand washing and other coronavirus protocols should be followed. A Smithsonian spokesperson said there is no specific timetable for reopening of the other museums, but more will reopen throughout the summer with all of them open by the end of the year.
The Montgomery County Council, sitting as the Board of Health, will hold a public hearing and vote Tuesday on regulation amendments that would add guidance for reopening the county based on the percentage of the population that has received at least one dose of the coronavirus vaccine. Currently, 49% of the county’s population has received at least one dose. The three phases of reopening would automatically be triggered when the Montgomery County Health Officer reports the vaccination progress to the Board of Health, according to a press release. Reopening phases would still require the continued use of face masks and social distancing. When 50% of the population has received at least one dose, the proposed guidelines include gathering limits increasing to 50 people indoors and 100 people outdoors; businesses limited to 25% capacity would move to 50% capacity if they do not sell or permit the consumption of food or drink; camps would move to gathering limits of 50 people indoors and 100 outdoors; escape rooms would be allowed 10 people per game; museums and galleries could reopen touch exhibits; malls could reopen pedestrian concourses and return tables and chairs inside; and sporting events could move to 50 people indoors and 100 outdoors with a similar number of spectators. At 60% of the population receiving at least one dose of the coronavirus vaccine gathering limits would increase to 250 people indoors and no limit outdoors; most businesses could move to 75% capacity and may sell food and drink for consumption while seated; camps would increase to gathering limits of 250 people indoors with no capacity limit outdoors and may permit campers from outside the DMV; convention and banquet facilities would be limited to 50% of the facility’s maximum capacity per Maryland restrictions; cigar and hookah bars could permit smoking outdoors; food service establishments could move to 75% of capacity; religious facilities could move to 75% of maximum capacity; and sporting events could increase capacity for participants and spectators to 250 people indoors and no limit outdoors. Under the proposal, with 50% of the population fully vaccinated, all conduct and business in Montgomery County would follow state or Maryland Department of Health requirements in place at the time. If County Health Officer Dr. Travis Gayles finds that after reviewing community transmission data that continued reopening phases would be contrary to public health, the health officer must report those concerns to the Board of Health, and the continuation to the next phase would be suspended pending a hearing before the board. The deadline to sign up to speak at the public hearing is 5 p.m. Monday. Information on how to sign up to testify is on the county website.
Jacqueline Pogue Lyons, president of the Washington Teachers’ Union, said families who want in-person learning in the fall should receive it. It is the union’s strongest endorsement of in-person learning since the pandemic closed campuses more than a year ago. Pogue Lyons also warned that some families will be reluctant to return. She said D.C. Public Schools should offer virtual options to students with health concerns and maintain strict safety precautions inside schools. “Certain communities really have been ravaged by this pandemic, so we have to give them the support that they need so that they feel comfortable and safe in coming back,” Pogue Lyons said Friday. “That takes time.” Mayor Muriel Bowser said Monday that students will be required to attend in-person classes five days a week when the 2021-22 school year starts in August. She said schools would evaluate requests from families who want to continue with remote learning. DCPS, which educates about 50,000 students, is currently offering limited in-person instruction. About 30% of students in the district are receiving face-to-face instruction at least once a week, according to DCPS data. But the demand is not evenly distributed across the city, with students in affluent neighborhoods returning at higher rates than students in low-income neighborhoods. DCPS allowed schools to expand in-person learning in the fourth quarter, which began earlier this week. More than 1,700 seats were added in Ward 3, the wealthiest part of the city. By comparison, 48 seats total were added in Wards 7 and 8, areas of the city with large concentrations of low-income families. Pogue Lyons conducted a walkthrough of McKinley Technology High School in Eckington on Friday morning, touting the campus as a model for how schools can safely reopen. Many educators have become more comfortable with working in person after becoming eligible for the COVID-19 vaccine. More than 2,500 teachers in the school system are back in physical classrooms. The WTU president said DCPS must start building trust with underserved families who have suffered the most severe health and financial consequences of the pandemic. That includes encouraging parents and children 16 and older to get the COVID-19 vaccine and making sure federal relief dollars flow to schools. “If we want to come back fully in the fall, there’s lots of details that we need to start working on right now,” she said. Chancellor Lewis D. Ferebee, who also participated in the walkthrough, acknowledged some families are still uneasy about in-person learning. But he said the school district will work over the summer to convince families it is safe, adding DCPS has invested in many building improvements, including HVAC upgrades. “This is the optimal place for students to learn,” he said, standing outside McKinley. “This is the optimal place for students to receive the supports they need and the socio-emotional development parents and guardians are asking for.” Sherice Muhammad, the mother of a senior at McKinley who helped the school develop plans for reopening, said the school brought back students who failed one class or more for in-person learning. About 70 teenagers at the school in Northeast are receiving face-to-face instruction at least once a week, according to Muhammad, who chairs the school’s Local School Advisory Team, a panel of parents, teachers and staff. Class sizes are capped at 10 students to maintain physical distancing and four classes operate each day. She said she hopes more families will feel safe sending their children back for summer classes. Muhammad was critical of DCPS earlier this school year, chastising the district for what she viewed as a failure to communicate with parents and teachers. But she said communication has improved over the last several months. “We don’t want to do this in silos,” she said.
The University System of Maryland will require students, faculty and staff be vaccinated against COVID-19 before returning to campuses in the fall. Chancellor Jay Perman announced the decision in a press release Friday. The system will allow exemptions for medical or religious reasons, the statement said. “If we examine the data — and there is an extraordinary accumulation of data — we see that the risk of vaccines is very low, whereas the risk of COVID is very high. And that risk is increasingly falling on young people,” Perman said. The announcement came a day after the 10-campus University of California system and the 23-campus California State University system said they intend to require vaccines in the fall, in the largest announcement of its kind in American higher education. Across the country, colleges have been divided on the issue. Some private universities, including Johns Hopkins, American, George Washington and Georgetown, have told students they must get vaccinated, but other schools are leaving the decision to students. “We want students to have these bonding opportunities. We want them to have a college experience that breeds a sense of belonging. And if that’s our goal—to have students (a lot of students) safely back on campus this fall, then we have to do everything we can to protect that safety … the safety of our students; the safety of our faculty and staff; the safety of the communities we share with our neighbors, with whom we’ve built a relationship of mutual respect and mutual trust,” Perman said. USM will also continue with other mitigation strategies like pre-arrival COVID-19 testing, surveillance testing and public health interventions like masking. The system includes 12 universities and three regional higher education centers, including the University of Maryland and Bowie State University, serving about 135,000 undergraduate and about 41,000 graduate students, according to its website.
Prince George’s County launched an online COVID-19 vaccination clinic search tool to help residents get vaccinated. The county’s vaccine website has an interactive map, allowing users to search for vaccination clinics across the county. Once a user browses through search results, he can select a provider to get more information about that clinic and where to sign up for an appointment. “Now that every person 16 and older who lives or works in the county can get vaccinated and more clinics are opening up, we want to ensure everyone can easily find where they can get these lifesaving doses as quickly as possible,” said the county’s Deputy Chief Administrative Officer for Health, Human Services and Education Dr. George L. Askew. The website allows users to search for clinics within a 20-mile radius using an address, ZIP code or a place name. Links and phone numbers to clinics are provided. A link to Maryland’s statewide vaccine clinic locator is found at the bottom of the clinic search results list as well. More than 288,000 county residents have received at least one dose of a COVID-19 vaccine, according to state data, which is a little less than a third of the county’s population.
Virginia will expand capacity at sports and entertainment venues and increase the limit on social gatherings beginning midnight on May 15. With more than half of all adults having received at least one dose of the coronavirus vaccine and numbers expected to rise now that those 16 and older are eligible for a vaccination, Gov. Ralph Northam said Thursday that some pandemic-related restrictions can be relaxed. Social gatherings can increase to 100 people indoors and 250 outdoors. Indoor entertainment and amusement venues may operate at 50% capacity or 1,000 people, up from 30% capacity or 500 people. Outdoor entertainment and amusement venues may operate at 50% capacity with no numericc cap on the number of attendees. The number of spectators allowed at indoor recreational sporting events will be 50% capacity or 250 people, whichever is less. While outdoors, the number of people can increase to 50% capacity or 1,000 people, whichever is less. Restaurants may resume selling alcohol after midnight, and dining rooms no longer have to be closed between midnight-5 a.m. The order also rolls back restrictions on bar seating or “congregating areas” of restaurants, which had been closed since the start at the pandemic. Under the new order, bar seating can be used if there is six feet between customers. “I’m optimistic that we will be able to take more steps in June. We are working to significantly ramp up vaccinations even further and aim to reduce capacity limits in June, hopefully all the way,” Northam said in a statement Thursday. However, he said several measures need to continue, including the wearing of masks, social distancing and getting vaccinated. The latest order follows increased accommodations Northam allowed earlier this week for school sports and performances.
Criminal and civil jury trials are set to resume in Montgomery County on Monday following an extended shutdown during the pandemic. Trials stopped on March 13, 2020 at the beginning of the pandemic as part of a statewide closure of the court system. Courts across the state reopened in a five-phase approach, with jury trials returning in early October. But Maryland Court of Appeals Chief Judge Mary Ellen Barbera ordered trials suspended on Nov. 16, following a jump in COVID-19 cases and deaths across the state. Montgomery County State’s Attorney John McCarthy said Thursday his office has continued to operate throughout the shutdown and has gone through a number of potential plea negotiations. “Our attorneys are ready to go. We do have a fairly large number of cases backed up, as anyone would imagine,” he said. McCarthy estimated that the State’s Attorney’s Office has a backlog of about 300 cases, but many will end in pleas. Initially juries for two cases will be selected per day, McCarthy said. That could change as vaccinations in the community increase and COVID-19 cases decrease. McCarthy said a number of courtrooms were retrofitted with plexiglass dividers to protect witnesses, attorneys and judges from exposure when trials resumed in October. There will also be limits on the number of spectators allowed in courtrooms, and everyone entering the courthouse must have their temperature checked. Jurors must answer a series of pre-screening questions about whether they have had or have been exposed to the virus before they come to court, McCarthy said. “They can be excused by jury commissioner without having to come to the courthouse,” he said. McCarthy said he expects that photos and documents that are entered into evidence will be displayed to the jury as a whole in order to minimize the risk of transmission. “Sometimes we’ll literally pass a picture to the jury to look at. Well, you’re not gonna pass a document from juror to juror to juror. You’ll put it up on a screen so that they can uniformly see it. You’re not gonna allow the virus to be spread by virtue of touch from person to person,” he said. McCarthy said that in some of the older criminal cases the parties have elected to plead out because of factors such as witnesses’ memories of events fading.
When the 2021-22 Fairfax County Public Schools year begins in the fall, the goal is for a return to pre-pandemic normal. “That means we will have students attending in-person learning, five days a week, period,” Supt. Scott Brabrand told the school board Wednesday. While extolling the benefits of in-person learning, Brabrand said FCPS will offer limited virtual learning next year for students who meet specific criteria who want to remain online. “FCPS and I pledge today that we are going to work with every family by name and by need, to ensure that they are confident in returning their children into our school buildings this fall,” Brabrand said. Since Virginia Gov. Ralph Northam signed a law requiring school districts to offer full-time, in-person learning, FCPS will apply COVID-19 mitigation guidance from the Centers for Disease Control and Prevention “to the maximum extent possible,” Brabrand said. In-school transmission of the coronavirus has been exceedingly rare when proper mask usage and social distancing guidelines are followed. “We’re hearing already from the CDC director and Moderna that the vaccine will available in just a few more weeks to kids as young as 12-years-old,” said Brabrand. “That’s all of our middle and high school kids in the next few weeks, all being able to be vaccinated.” Northam has said he would not seek to make COVID-19 vaccines mandatory for college students School bell and bus schedules will more closely resemble what they were prior to the pandemic’s arrival in March 2020. The School Age Child Care program will return to its before- and after-school model. Brabrand said the district is looking for creative ways to increase the physical distance between students in typically crowded cafeterias and some school classrooms. “We will be increasing capacity for learning and lunches through the purchase of additional tents for outdoor classrooms, to support adherence to CDC social distancing guidance to the maximum extent practical,” he said.
Georgetown University will hold in-person graduation ceremonies at National Park on May 24. In a letter to the university community, President John J. DeGioia there will be a morning ceremony for undergraduate students and an afternoon ceremony for graduate and professional students. Graduates may bring two guests, but the ceremonies will also be broadcast virtually for those unable to attend in person. The university’s plan was approved by the D.C. government on Thursday, DeGioia said. All attendees are expected to follow D.C.’s public health and travel guidance. Details are still being worked out, including a contingency plan if adjustments are needed for public health or other reasons. “We made a commitment to the Class of 2020 and the Class of 2021 that we would provide an opportunity to gather on campus and celebrate graduation with family and friends. As we see the possibility for large gatherings emerging, we are beginning to plan for these events in 2022,” DeGioia said. More information is available on Georgetown’s graduation website. Georgetown joins other schools in the DMV that are also planning in-person graduations, including American University, the University of Maryland and Catholic University.
The U.S. Department of Agriculture this week extended waivers through the 2021-22 academic year that allow school districts to distribute free meals to children. The extension expires in June 2022. Before the announcement, the waivers would have expired in September. The waivers allow meals to be served at no cost in bulk and to parents without their children being present. They were first passed at the beginning of the COVID-19 pandemic as worries about food insecurity rose. “USDA will remain relentless in ensuring our nation’s children get the critical nutrition they need,” Agriculture Secretary Tom Vilsack said in a press release. “States and districts wanted waivers extended to plan for safe reopening in the fall. USDA answered the call to help America’s schools and childcare institutions serve high quality meals while being responsive to their local needs as children safely return to their regular routines. This action also increases the reimbursement rate to school meal operators so they can serve healthy foods to our kids. It’s a win-win for kids, parents and schools.”
Costco pharmacies will administer COVID-19 vaccinations “as soon as they are available.” “We are receiving a limited amount of vaccine,” the company said in press release Thursday. Users could receive a message saying “the resource you selected is not available” if there are no appointments available. “Please check back at a later time and do not contact the local Costco pharmacy as they are unable to schedule an appointment,” the company said. Appointments can be booked https://book-costcopharmacy.appointment-plus.com/d133yng2/#/book-appointment/select-a-location?_qk=uytked8glhq online.
On Wednesday, Maryland Gov. Larry Hogan pledged an “all hands on deck” effort to get every Marylander vaccinated against COVID-19 as part of a “No Arm Left Behind” campaign that includes focusing on senior citizens who still haven’t received a vaccination, encouraging college students to get vaccinated and partnering with some of the state’s largest employers to vaccinate employees. As of Wednesday, more than 82% of Marylanders 65 and older have been vaccinated, according to the Maryland Department of Health. The new campaign includes “redoubling our efforts to reach that remaining 18% of Maryland seniors by going county-by-county and ZIP code-by-ZIP code in an effort to get every senior vaccinated,” Hogan said during a press conference Wednesday. The state is also reaching out directly to more than 70,000 of the state’s Medicaid recipients 50 and older who have not yet received a vaccine. “We’re booking appointments for more of them every single day,” Hogan said. The number of vaccine providers in the state including pharmacies, hospitals, clinics set up by the state’s Vaccine Equity Task Force and mass vaccination sites total more than 3,000, Hogan said. To ease access, no-appointment walk-up options are expanding at the state’s mass vaccination site starting today, including at the Navy-Marine Corps Memorial Stadium in Annapolis, the Baltimore Convention Center Field Hospital and the Greenbelt Metro station, which is run by the Federal Emergency Management Agency. The state is also enhancing its vaccine support call center to provide direct assistance to people who are homebound or who need transportation or tech support to get vaccinated. The call center’s number is 855-MD-GOVAX and is available daily from 7 a.m.-10 p.m. Hogan encouraged all students at Maryland colleges to get vaccinated and said the state health department was reserving appointments specifically for university students at the state’s mass vaccination sites, including the Greenbelt site. Hogan said the decision as to whether require vaccinations before students can return to campus should be left to each university or university system. “I know a number of colleges across the country are mandating it and, you know, we would encourage them to do so, but that’s not an action that requires any executive order or any health department order from us,” Hogan said. The state’s equity task force is partnering with two historically black universities to launch vaccine clinics. Bowie State University will host a joint town hall-vaccine clinic April 26 and Morgan State University will host a three-day walk-up clinic beginning April 30, Maryland National Guard Brig. Gen. Janeen Birckhead, who leads the task force, said. Hogan said the state would also partner with some of its largest employers including Southwest Airlines, Exelon, Comcast and Amazon to make sure their employees get vaccinated. Overall, the state has administered more than 4 million shots and more than 55% of adult residents have been vaccinated. “We’re actually ahead of where we thought the max capacity was, but we’re going to keep going. I’d love to see 100% of the people [vaccinated], but I don’t think anybody ever anticipated getting to that level,” Hogan said. At some point, and perhaps soon, Hogan said he expects the state will see demand for the vaccines start to slack off. “We want to keep [appointments] filled and keep moving at the same pace … but we’re having to do lots of creative things to get the same number of vaccines done every day.” For example, Hogan said, the state is starting to see more no-shows at its mass clinics, which he speculated was because there are so many additional options for getting shots, and people were finding opportunities even after booking appointments.
Forty-six percent of Montgomery County residents have received at least one dose of the vaccine and 29% has been fully vaccinated. “And when you take out the people who can’t get vaccinated, it’s actually a much higher percent. And so we’re really happy about where we’re moving with this,” County Executive Marc Elrich said during a press conference Wednesday. “However, our Germantown mass vax site saw a 20% reduction in doses this week … which is really problematic. And that comes about obviously from the shortage of supply.” Elrich said the problem can be traced back to manufacturing problems with the Johnson & Johnson vaccine, “as well as the failure of other supplies to materialize adequately to replace what we lost from Johnson & Johnson.” Still, he credited residents for the high vaccination percentages. “I know not everybody jumped up and down and said, ‘Yes, I love doing this,’ but the fact is that most residents have worked with us and followed the kind of guidance we’ve given them. Because they follow the guidance, we have the numbers that we have,” Elrich said. “And because we have the numbers that we have, we’re beginning to look now at how we move toward reopening. We’ll be providing guideline metrics that are achievable metrics, not aspirational metrics.” Earl Stoddard, director of the county’s Office of Emergency Management and Homeland Security, said there was a “significantly high scientific literacy rate in Montgomery County. … We have a population that’s very willing to follow the guidance and guidelines of our public health leaders, not just in the county, but across the country. And so I think that well-informed population matters.” Elrich said more information on reopening would be coming.
Gaithersburg-based Emergent BioSolutions’ Bayview factory in Baltimore, which Johnson & Johnson hired to make its COVID-19 vaccine, was dirty, didn’t follow proper manufacturing procedures and had poorly trained staff resulting in contamination of material going into a batch of shots. On Wednesday, the Food and Drug Administration released a statement and a 13-page report detailing findings from its just-completed inspection of the idled plant. FDA inspectors said a batch of bulk drug substance for J&J’s single-shot vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent client, AstraZeneca. The batch, reportedly enough to make about 15 million J&J vaccine doses, had to be thrown out. Other problems cited in the inspection report included peeling paint, black and brown residue on factory floors and walls, inadequate cleaning and employees not following procedures to prevent contamination between vaccine batches and ingredients. Nothing the factory made for J&J has been distributed, the FDA noted. The nearly 8 million doses of J&J vaccine given in the U.S. came from Europe. Both Emergent and Johnson & Johnson said Wednesday that they are working to fix the problems as quickly as possible. After quality problems surfaced late last month, J&J took control of the factory. The Biden administration now is working to move AstraZeneca vaccine manufacturing to another factory. AstraZeneca has yet to seek emergency authorization for use of its vaccine in the U.S. The factory halted all production late last week at the FDA’s request. The agency hasn’t given emergency approval to the factory, which is needed before any vaccine material made there can be distributed. All the bulk vaccine substance inside Emergent’s factory, plus early batches made there and then put in vials and packaged by other J&J contractors, are being stored and will undergo additional testing by the FDA, the agency said. “We are doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and effectiveness,” the FDA said. Currently, use of the J&J vaccine is paused in the U.S. as health officials investigate a possible connection to very rare blood clots. Their decision on whether to allow its use to resume could come Friday. On Tuesday, the European Medicines Agency’s safety committee concluded the blood clots are a very rare side effect but that the vaccine’s benefits outweigh that risk. Emergent, a little-known drug manufacturing contractor, has been repeatedly cited by the FDA for problems ranging from poorly trained employees to cracked vials and mold around one of its facilities, according to records. After the J&J vaccine batch was contaminated, FDA inspectors began inspecting the Emergent factory on April 12 and finished their investigation Tuesday. Inspectors also reviewed security camera footage, which showed employees carrying unsealed bags of medical waste around in the factory, with the bags touching materials ready to be used to make vaccine batches. The footage also showed employees moving between manufacturing areas for the two vaccines without documenting whether they changed protective gowns and showered in between, as well as removing protective clothing in the warehouse near prepared vaccine ingredients, dropping the clothing on the floor and then tossing it in open trash cans. The report noted that Emergent didn’t sufficiently investigate the contamination of the later-discarded J&J batch and didn’t appear to have done any extra cleaning after it was discovered. “There is no assurance that other batches have not been subject to cross-contamination,” the report stated. It noted other problems at the factory include inadequate procedures for assuring the vaccine met all quality and purity requirements, and floors and walls too damaged to be properly sanitized. The plant also was too small and not properly designed for thorough cleaning, maintenance and operations, inspectors said. It isn’t clear how long it will take the companies to resolve the problems. However, Emergent issued a statement on Wednesday saying it is “committed to working with the FDA and Johnson & Johnson to quickly resolved the issued identified. We deeply value the relationship we have with our manufacturing partners and with the FDA. The FDA’s feedback will help us continue to improve and strengthen the supply chain for Johnson & Johnson’s COVID-19 vaccine. While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.” Johnson & Johnson said in a statement Wednesday it “will exercise its oversight authority to ensure that all of FDA’s observations are addressed promptly and comprehensively. The company will also redouble its efforts as it continues to work toward securing Emergency Use Authorization in the United States for drug substance manufactured at Emergent Bayview as quickly as possible, so that the company can help bring an end to this global pandemic.”
Madam’s Organ blues bar and restaurant in Adams Morgan is asking D.C. Mayor Muriel Bowser for permission to fully reopen by requiring every person in the club to provide proof of COVID-19 vaccination. “We’re not asking for a government-mandated vaccine passport,” wrote owner Bill Duggan, in aFacebook post that was emailed to Bowser. “We’re asking for permission to open with our own strict safety guidelines.” The plea comes as indoor, limited live music is set to resume in D.C. on May 1. Earlier this month, Bowser announced seated live entertainment venues may reopen at 25% capacity or 500 people, whichever is less. Previously, some live entertainment was allowed after a venue received a waiver through from the city’s Homeland Security and Emergency Management Agency. Bowser said D.C. is reviewing the current requirement that seats be more than 30 feet from the stage. Duggan said his staff, musicians and patrons “have been abiding by the COVID restrictions and patiently awaiting the day that our doors could reopen. That day is here — or very near,” he said. “We now have vaccines. My staff is close to 100% vaccinated. We have worked diligently to help them get their appointments and have even driven them to those appointments. Our musicians are doing the same and may have told us that their bands are 100% vaccinated as well. We want everyone to be safe and we are willing to do the work to guarantee that safety, if you allow us.” Duggan said staff already checks IDs at the door. “ABRA [D.C.’s Alcohol Beverage Regulation Administration] is already trained to guarantee that we do,” Duggan said. “Our door person can now also check that each and every employee, artist and patron shows proof of vaccination before being allowed inside. ” he said. “Checking for compliance on this rule, if allowed, would not add much further burden.” Duggan said approving the request would also benefit the city’s efforts in convincing residents to get vaccinated. “This would be a cost-free and very effective incentive to vaccinate … a return to semi-normalcy, if, by just getting vaccinated, employees could return to work, artists could perform and patrons could again visit their favorite bar, restaurant or business, many, if not most, will choose to get the shot. It’s a win-win-win-win,” Duggan said. “And so, in the words of the great James Brown … Please, Please, Please.”
Montgomery County high school seniors will be able to graduate in-person this year. The Montgomery County Council on Tuesday approved a Board of Health regulation that will allow such graduation ceremonies, but with restrictions. In a unanimous vote, members approved outdoor ceremonies limited to 50% capacity. Indoor ceremonies will be restricted to 25% capacity or 250 people, whichever is smaller. Schools that plan to hold an indoor ceremony must obtain a letter of approval, showing how they will meet the general requirements. A record of everyone attending the ceremony must be kept for 30 days to enable contact tracing. No more than 10 people can be on the stage at one time, and the ceremony cannot last no more than two hours. Also, diplomas must be distributed without handshakes or physical contact. Audience members from different households must remain at least 6 feet apart at all times. Rami Kandel, the parent of a graduating senior, said his son experienced a year without many of the things that make senior year special. “No homecoming dance, no fall football nights, no class of ’21 car decorating, no prom, none of the last year together celebration milestones,” he said. “Let them have their in-person graduation — outdoor, socially-distanced graduation.”
Virginia Gov. Ralph Northam increased attendance limits for performance events like high school musicals and concerts. During a press conference at the new mass vaccination site at the former Lord & Taylor store in Tysons Corner Center that opened Tuesday, Northam announced the spectator cap for school performances, including musicals, is increasing to 100 attendees or 30% of capacity, whichever is less, for indoor venues up from the previous limit of 50. Outdoor venue capacity will be 500 or 30%. “I’ve heard a lot of feedback from parents and students that these events should be treated the same as athletic events, and I agree,” Northam said. “We’re on the right track, we just need to keep being careful and vigilant.” Northam also raised the limit on the number of cross-country runners who can line up at a starting line to 68, up from 50. He expects to release more details on the caps in the coming days. Parents and local officials had been pressuring the governor to bring limits on school performances more in line with sporting events. Last week, Loudoun County School Board members joined interim superintendent Scott Ziegler in decrying an executive order preserving tighter attendance restrictions on school performances than sporting events or independent entertainment venues.
The Maryland Department of Health has hired an adviser to support vaccination efforts reaching vulnerable and underserved communities in Prince George’s County. Katina Rojas Nazario-Joy will “provide advisory and operational support to our vaccination team,” said David McAllister, a spokesperson for MDH’s Office of Preparedness and Response. Her duties will include connecting with “community leaders and county residents to promote and improve vaccine administration in Prince George’s County, as well as to provide communications support to the team,” according to McAllister. The hire comes after months of lagging county vaccination rates and state efforts to focus on vaccinating the county’s Black and Brown population. As of Tuesday, about 19.6% of Prince Georgians were fully vaccinated, according to MDH data. For months, Prince George’s had the lowest percentage of vaccinated adults in the state but surpassed Somerset County on Monday. To help vaccination efforts, the Federal Emergency Management Administration on April 7 opened a mass vaccination clinic at the Greenbelt Metro station with the capacity to vaccinate up to 3,000 people per day. This is the first federally-operated site in the state and FEMA’s second mass vaccination site in the county. According to Nazario-Joy’s LinkedIn profile, she is the “Prince George’s County COVID-19 Coordinator and Advisor to the Secretary of Health.” She previously worked for the county as a Latino liaison under County Executive Angela Alsobrooks in the Stakeholder and Engagement Affairs Division, according to Gina Ford, a spokeswoman for Alsobrooks. Nazario-Joy held the position for just more than a year, according to her LinkedIn profile. Nazario-Joy has also worked for the U.S. Department of Commerce and in sales for Novartis and AstraZenica, , pharmaceutical companies. In a statement, Alsobrooks congratulated Nazario-Joy on her new position. “I am certain she will bring her tremendous knowledge and passion to this position,” she said. Ford wasn’t aware of Nazario-Joy’s hiring or responsibilities.
Jobless workers in Virginia collecting unemployment benefits will be required to look for work beginning in early June. The work search requirement had been suspended during the pandemic. But according to an announcement Tuesday from the Virginia Employment Commission, it will be reinstated effective the week ending June 5. Claimants must search and report two job searches each week. The requirement will also apply to people who get Pandemic Unemployment Assistance. “With increased vaccination access, first in the national workplace safety regulations and a robust demand for workers from businesses, Virginia will resume collecting and reviewing work search activities of customers,” said Commissioner Ellen Marie Hess.
New TSI Holdings, which owns Washington Sports Club, will pay D.C. $100,000 as part of a settlement over charges it didn’t adhere to the city’s COVID-19 emergency protocols and put customers at risk. The settlement marks another legal battle between D.C. Attorney General Karl Racine and the chain, which has been accused of making it difficult for members to cancel their memberships and not following the city’s COVID restrictions. “The District put emergency orders in place to help protect the health and safety of residents and reduce the spread of COVID-19,” Racine said in a press release Tuesday. “Unfortunately, Washington Sports Club created an environment that not only violated those rules and put District residents at risk but also had the potential to spread COVID-19.” Under the agreement, New TSI Holdings has seven days to pay $100,000 in penalties. The company must immediately follow the city’s COVID-19 safety protocols, post signs on its doors stating mask requirements, ask any member who refuses to wear a mask to leave and update its website to include information about social distancing guidelines. The company must also follow Phase 2 reopening guidelines, which currently limit fitness centers to 25% of capacity as well as any future restrictions Mayor Muriel Bowser imposes. If the company follows these requirements, the agreement says it is free from charges brought forth by the city. This was the third time Racine’s office has sued TSI Holding since January 2019. At the time, the office filed the first in a series of lawsuits against the company for failing to inform members about the company’s cancellation policy and continuing to charge customers who did cancel their memberships. Racine’s office also settled with TSI Holdings in 2016 over deceptive cancellation practices, and the company agreed to stop misleading customers about its cancellation policies. But since then the office said it is aware of at least 50 complaints claiming the company has continued to mislead customers about cancellation policies and additional fees. “TSI often tells consumers that they can cancel their memberships at any time for free; however, TSI actually requires six weeks written notice for cancellation and charges cancellation fees,” Racine’s office said at the time. In August 2020, Racine’s office filed the second suit alleging TSI Holding continued to charge customers late fees and did not let many cancel their memberships after Bowser’s stay-at-home orders took effect in March. Racine and other states’ attorneys general sent the company a letter last April asking it to stop charging membership dues to gym members during the public health emergency. The company responded 24 days later saying it would freeze all customer accounts and reimburse dues paid when its gyms were inaccessible. However, after the company’s gyms reopened June 22 it had yet to follow through on its promise, and Racine’s office filed another suit. Last month, Racine’s office sued the company again, this time over allegations that the Dupont Circle location failed to enforce the city’s mask mandate. Multiple gymgoers filed complaints with the city claiming the gym allegedly failed to enforce the mask mandate, did not set and enforce appropriate social distancing guidelines and failed to properly disinfect equipment required under D.C.’s emergency order. TSI Holdings currently owns three Washington Sports Clubs Dupont Circle, Columbia Heights and Glover Park. The company closed three other locations during the pandemic. The company operates more than 150 gyms across the country and faces similar accusations of deceptive business practices in New York City and Boston.
After months of free parking in D.C., the city will restart parking enforcement on June 1. The Department of Public Works will resume enforcement of expired parking meters, residential parking permits, vehicle tags and other violations. It will also resume ticketing and towing vehicles that are in no-parking zones and abandoned vehicles with flat tires or expired registration. Officers will also enforce rules regarding the registration of out-of-state automobiles, as well as no-parking rules for street sweeping. Beginning July 1, DPW will boot vehicles with two or more tickets that are more than 60 days old. Also on July 1, all D.C. driver license and ID card holders must have a valid credential. Vehicle registration and REAL ID license can only be renewed online or by mail. Only new drivers, new residents or people requiring a new REAL ID must report in person. Vehicle inspection is available on a first-come, first-served basis. While drivers got a pass on many violations during the pandemic, DPW never stopped ticketing for safety violations like blocking crosswalks, fire hydrants or bike lanes. School zone parking enforcement resumed on March 15. “We know we can expect to see more activity on our roads and sidewalks, and these enforcement mechanisms are one way we can make our transportation network more efficient, restart important government services and help protect residents and visitors as they move around D.C.,” Mayor Muriel Bowser said in a press release. D.C.’s potential revenue from parking tickets was cut in half as people stayed home and the city suspended enforcement of parking violations. But city officials have also said that as they start ramping up enforcement and collecting revenue again, they want to be sensitive to the impact of unpaid or outstanding tickets, especially for drivers who may have been financially impacted by the pandemic. To address that, D.C. will launch an amnesty program waiving late fees on tickets. Most parking fines double after 30 days. The four-month program applies to parking, red light, speed and stop sign camera tickets, as well as minor moving violations. There is currently about $400 million in outstanding tickets, Babers said. It will run from June 1 through Sept. 30, and all tickets issued before Sept. 30 are eligible. DPW tow and storage fees will not be waived. Starting June 1, people with tickets who are facing financial hardship should contact the D.C. Central Collection Unit for settlement options. Any ticket included in a settlement plan will not be eligible for adjudication. “In addition to getting many drivers in compliance with their ticket obligations, the amnesty program will help District residents pay their outstanding tickets so they can obtain a REAL ID credential and obtain assistance if they face financial hardship due to the pandemic,” said Deputy Mayor for Operations and Infrastructure Lucinda Babers. Also starting June 1, households with multiple cars will pay more to park those vehicles on residential streets. The first vehicle will cost $50 a year, up from the previous $35. A second vehicle will cost $75, a third $100 and every additional vehicle will cost $150. An exemption exists for one resident per household 65 years of age or older; they will pay a $35 annual RPP fee for the first vehicle registered at a legal mailing address, up from $25 previously. The fee for each subsequent vehicle registered at a legal mailing address is the same.
Montgomery County officials plan to add COVID-19 vaccine walk-up, no-appointment lines and create an open appointment portal not limited to phases at its vaccination clinics and sites soon. Earl Stoddard, executive director of the county’s Office of Emergency Management and Homeland Security, said during a press conference Monday held by Council President Thomas Hucker that the county is considering adding the walk-up lines and portal in mid-May. “I think you’ll likely see us start with just having more and more open appointments for people to just go to the portal online, pick a time and show up at that time,” he said. “Then we’re likely to expand into where you don’t need to have anything done in advance — you show up and we register you onsite.” Smaller clinics with onsite registration could be targeted for areas where the county has had higher proportions of people not vaccinated. “We’re going to let the public interest and behavior tell us when to move forward,” Stoddard said. “Meaning, as soon as we start to see a lag in how quickly we fill our clinics, we’ll [pick a date].” About 135,000 people have preregistered for a vaccination with the county, but have not received one yet. Of those, a little less than 90,000 have received an invitation for an appointment. Most of the remainder will probably receive an invitation over the next two or three weeks, Stoddard said. About 1,300 people who have signed up for a vaccine are homebound. About half of those have been vaccinated. State deliveries of vaccine to the county have decreased due to the Johnson & Johnson vaccine being paused and mass vaccination sites opening and needing doses. The county halted use of the J&J vaccine last week after federal agencies began reviewing whether six cases of rare blood clots are related to the vaccine. The county had a 20% reduction in doses for the mass vaccination site at Montgomery College’s Germantown campus and is providing 1,200 first doses a day, which is half the capacity of the site, Stoddard said. “It’s going to look pretty empty,” he said of the site, adding that the dose deliveries are expected to continue to decrease as more state sites open. “We were clamoring for the opening of our site, so I can’t begrudge any other community for clamoring for the opening of a site in their location,” he said. “We’ve been hearing about this avalanche of vaccines coming for almost two months now and we’re still waiting.”
D.C. will begin vaccinating homebound residents in their homes on April 26. D.C. Mayor Muriel Bowser said during a press conference Monday that homebound residents can begin calling the D.C. Health call center at 855-363-0333 between 8 a.m.-7 p.m. weekdays and 8 a.m.-4 p.m. weekend to schedule an appointment. Any homebound resident, regardless of age, is eligible to receive a COVID-19 vaccine appointment. The program’s launch comes after D.C. councilmembers repeatedly requested the program during weekly calls – which Bowser discontinued — with the administration. For several weeks, D.C. Health officials said the department was looking at ways to vaccinate homebound residents. The city was prepared to begin accepting registrations late last week, but on Wednesday, D.C. Health Director Dr. LaQuandra Nesbitt said the pause of the Johnson & Johnson vaccine delayed the launch. During the press conference Monday, Nesbitt tried to walk back that statement, saying “last week, the program was not live because the program wasn’t ready to go live.” If the pause on the use of the one-shot Johnson & Johnson vaccine is not lifted before next Monday, Nesbitt said, the city is prepared to administer the Moderna vaccine to homebound residents. “We had a discussion where our preference for any home visiting program that uses vaccines would be more efficiently executed or implemented with a one-dose vaccine. However, it doesn’t preclude us from being able to use two-dose vaccines out in the community,” she said. According to Nesbitt, D.C. Health has already identified individuals for homebound appointments through partnerships with various home health and government agencies, and she encouraged anyone who needs a vaccine at home to register for an appointment this week, saying that the program would work most efficiently based on the sign-up system. But she cautioned that administration could take longer and proper transportation of the doses could be more complicated if only a few residents are booked for appointments in neighborhoods across the city. “We’re not going to go out in the field with only two people registered,” Nesbitt during the press conference. “So amplifying this program, making sure people call in is going to be extremely beneficial.” Meanwhile, D.C. is still looking at other ways to boost vaccine rates for seniors. While all D.C. residents are now eligible for a vaccine through D.C. Health’s registration system, Bowser noted on Monday that there are still thousands of residents who are not yet connected with the city’s pre-registration portal. Only about half of the city’s seniors have been fully vaccinated. On Monday, D.C. opened 10 walk-up sites for residents 65 and older that do not require an appointment. D.C. Health is still struggling to reach seniors in Wards 7 and 8. Both wards have seen far lower vaccination rates than wealthier wards since the city began distributing vaccines.
Marymount University will offer the Pfizer-BioNTech COVID-19 vaccine to all students, staff and faculty on its main campus, 2807 North Glebe Road, Arlington, from 9 a.m.-5 p.m. Wednesday. Marymount in a press release said the effort arose as part of Gov. Ralph Northam’s recommendations. Everyone 16 and older became eligible to be vaccinated in Virginia on Sunday. “Everyone in the university community is encouraged to take advantage of it in order to be fully vaccinated before the summer,” the release said. “As Pfizer’s vaccine requires two doses for maximum protection, community members have the option to receive their second shot on campus in three weeks or at any Safeway close to their location off campus.” The vaccinations will be administered at the Rose Bente Lee Center.
George Washington University will require all students, faculty and staff to be fully vaccinated against COVID-19 before returning to campus this fall. “We continue to be encouraged by the progress we make each day toward a post-pandemic university, country and world,” President Thomas LeBlanc said in an email to the community on Monday. “We expect the availability of vaccines to increase, allowing everyone age 16 and above the opportunity to receive a COVID-19 vaccine this spring or summer.” Current students and staff should upload their vaccination record card to the school’s medical portal. For incoming students, the COVID-19 vaccine will be included as part of the immunization requirements. Any vaccine currently authorized or approved for use in the U.S. will be accepted. The school said it will work with international students who have received a vaccine not currently authorized by the Food and Drug Administration on a case-by-case basis. Exemptions will be granted on a limited basis, chiefly for medical or religious reasons. Students who are online-only and faculty who will only be teaching virtually in the fall, will not be required to receive the vaccine unless they plan to go to campus. Routine tests will not be accepted in place of vaccination. “We will exercise discretion in enforcing the mandate for those who have extenuating circumstances that are beyond their control and that will cause delays in vaccination,” LeBlanc said in his letter.
Gaithersburg-based Emergent BioSolutions, a key contract manufacturer for Johnson & Johnson’s COVID-19 vaccine, has stopped making bulk vaccine substance and is retaining what has already been made at its Baltimore Bayview plant while U.S. regulators continue inspecting it due to quality problems. The news was disclosed Monday in a Securities and Exchange Commission filing. It raises questions about whether problems at the factory will prevent J&J from meeting its U.S. supply commitments. J&J said it remained committed to providing 100 million doses of the single-shot vaccine pledged by the end of June. The company said “it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries.” Emergent said the U.S. Food and Drug Administration began inspecting the factory April 12 and four days later asked Emergent not to resume manufacturing and to quarantine all vaccine material already produced there. Emergent said it was doing so until the inspection was completed and the company addresses any problems found. The FDA declined to comment on how long its inspection will take. J&J disclosed on March 31 that it had to throw out a batch of bulk vaccine manufactured at the Emergent plant because it didn’t meet quality standards. The vaccine was mixed with material for the AstraZenica vaccine, which was also being produced at the plant. AstraZenica has since pulled its production from the plant.
The D.C. government denied a request from Capitol Hill Baptist Church to create a “COVID-immune section” for fully vaccinated parishioners. The church wanted to set aside 328 seats in its West Hall that wouldn’t have any social distancing requirements, but Christopher Rodriguez, D.C.’s director of Homeland Security and Emergency Management, denied the request last week after reviewing D.C. Health and Centers for Disease Control and Prevention guidelines. The church’s request did not include a relaxing of mask requirements. In a letter to associate pastor Jamie Dunlop, Rodriguez cited the most recent CDC guidance, which allows fully vaccinated people to meet indoors with each other “in [a] home or private setting” without social distancing or masks. He said the COVID-immune section would not allow for social distancing in a public setting that includes unvaccinated people from multiple households. According to the letter, Capitol Hill Baptist Church leaders requested the seating arrangement based on their interpretation of the CDC guidance that fully vaccinated people could be permitted to gather indoors with fewer restrictions. If the request had been granted, it would have been the first such approval in D.C. Other cities, including New York, have allowed fans into stadiums and entertainment venues with proof of vaccination. While D.C. didn’t grant the request, it did approve the church’s waiver request for a “non-immune” seating section with 6 feet between families. The proposal would allow up to 540 people to be seated indoors in seven different areas, twice the capacity allowed in Mayor Muriel Bowser’s latest order. A waiver is required for any gatherings over 250 people. The 850-member evangelical church sued the city and won last fall, when a federal judge granted its request to hold in-person services. The church previously sued D.C. on grounds that banning in-person religious services was unconstitutional, even gaining support from the U.S. Department of Justice. The church held its first pandemic outdoor service in October. “This permission is granted in a good faith effort to address CHBC’s concerns regarding capacity limits,” said in his letter approving the non-immune seating plan. “The total capacity CHBC proposes — and that we hereby permit — is beyond what we believe to be sound as a matter of public health.”