Biden’s election Six GOP-led states join Texas bid to overturn

17 min readDec 13, 2020

AUS government advisory panel convened on Thursday to decide whether to endorse large-scale use of Pfizer’s COVID-19 vaccine to help conquer the outbreak that has killed close to 300,000 Americans.

The meeting of outside advisers to the Food and Drug Administration represented the next-to-last hurdle before the expected start of the biggest vaccination campaign in U.S. history. Depending on how fast the FDA signs off on the panel’s recommendation, shots could begin within days.

The FDA panel functions like a science court. During the scheduled daylong session, it was expected to debate and pick apart the data — in public — on whether the vaccine is safe and effective enough to be cleared for emergency use. With unprecedented interest in the normally obscure panel, the FDA broadcast the meeting via Youtube, and thousands logged on.

“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” said FDA’s Dr. Doran Fink, who described agency scientists working nights, weekends and over Thanksgiving to get that done.

The FDA is not required to follow the committee’s advice but is widely expected to do so. Once that happens, the U.S. will begin shipping millions of doses of the shot.

Later this month, the FDA is expected to pass judgment on another vaccine, developed by Moderna and the National Institutes of Health, that has proved about as protective as Pfizer’s. Vaccine candidates by Johnson & Johnson and AstraZeneca are also in the pipeline.

The initial supplies from Pfizer and Moderna will be limited and reserved primarily for health care workers and nursing home patients, with other vulnerable groups next in line until the shots become widely available on demand, something that will probably not happen until the spring.

The meeting of experts on vaccine development, infectious diseases and medical statistics came as the coronavirus continues surging across much of the world, claiming more than 1.5 million lives, including about 290,000 in the U.S.

Hanging over the meeting was a warning from British officials that people with a history of serious allergic reactions shouldn’t get the vaccine. Government authorities there are investigating two reports of reactions that occurred on Tuesday when Britain became the first country in the West to begin mass vaccinations against the scourge.

Pfizer representatives told the panel they are aware of the British reports but have seen no signs of allergic reactions in their trial of the vaccine.

A positive recommendation and speedy U.S. approval appear nearly certain after FDA scientists issued an overwhelmingly positive initial review of the vaccine earlier this week.

FDA said results from Pfizer’s large, ongoing study showed that the shot, which was developed with Germany’s BioNTech, was more than 90% effective across people of different ages, races and underlying health conditions, including diabetes and obesity. No major safety problems were uncovered. Common side effects included fever, fatigue and pain at the injection site.

“The data presented in the briefing report were consistent with what we heard before and are really exciting,” said Dr. William Moss, head of Johns Hopkins University’s International Vaccine Access Center. “Nothing that I see would delay an emergency use authorization.”

The meeting also represented an opportunity for regulators to try to boost public confidence in the breakneck development process that has produced the Pfizer vaccine and a string of other upcoming shots with remarkable speed — less than a year after the virus was identified.

The FDA has also faced weeks of criticism from President Donald Trump for not rushing out a vaccine before Election Day.

When can I get a coronavirus vaccine?

“There have been a lot of questions about why it takes us so long or are we being rigorous enough?” FDA Commissioner Stephen Hahn said in an interview. “I’m hoping that people will see with our transparency that we have taken a very rigorous stance on this.”

Hahn said the agency had already teed up the process to authorize the vaccine by filling out all the legal paperwork in advance, regardless of the ultimate decision.

On Thursday’s agenda:

Rare Adverse Reactions

The FDA uncovered no major safety issues in its review of Pfizer’s 44,000-person study, including no allergic reactions of the type reported in the U.K. But such studies can’t detect rare problems that might only affect a tiny slice of the general population.

FDA reviewers noted four cases of Bell’s palsy that all occurred among people getting the vaccine. They concluded the cases were likely unrelated to the vaccine because they occurred at rates that would be expected without any medical intervention. But the agency did say cases of the nerve disorder should be tracked, given that other vaccines can cause the problem.

“I think we have to be upfront, without scaring people, that we don’t know yet about any potential, rare, long-term adverse events,” Moss said.

EXPLAINER: Allergic reactions to vaccines rare, short-lived

Efficacy Questions

The FDA found the vaccine highly effective across various demographic groups.

But it’s unclear how well the vaccine works in people with HIV and other immune-system disorders.

The study excluded pregnant women, but experts will tease apart the data for any hints in case women get vaccinated before realizing they’re pregnant.A study of children as young as 12 is underway.

What does COVID-19 vaccine effectiveness mean?

Impact of Emergency Authorization

Answering some of these questions will require keeping Pfizer’s study going for many more months.

When the FDA panel met in October, experts warned against allowing trial participants who received placebos to switch and get the real vaccine immediately after it receives the FDA’s emergency OK. Doing that could make it impossible to get answers to long-term questions, including how long the protection lasts.

Pfizer and BioNTech say they want to allow such participants to get the vaccine either upon request or, at the latest, after six months of follow-up.The FDA still hasn’t made clear if it will accept that approach.

“FDA is adamant that they want these trials completed,” said Norman Baylor, former director of FDA’s vaccine office, adding that its expert panel members “know that too.”

Vaccination cards will be issued to everyone getting COVID-19 vaccine, health officials say

AP writer David Koenig contributed to this story from Dallas. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Anne Arundel County became the latest Baltimore-area jurisdiction to announce new COVID-19 restrictions that includes closing in-person dining at restaurants.

|| Coronavirus updates | Maryland’s latest numbers | Where to get tested ||

Citing record numbers of COVID-19 cases, County Executive Steuart Pittman announced new restrictions that he feels will help reduce the spread of the disease.

“On behalf of the residents of Anne Arundel County, I’m sorry to bring you this kind of news, but I am heartened that so many of us believe that this is what we need to do,” Pittman said.

On Thursday, Anne Arundel County reported a new record high of 341 new COVID-19 cases, and a record high COVID-19 seven-day average case rate of 47.7 per 100,000 residents.

“We are in the midst of a dangerous surge,” Anne Arundel County Health Officer Dr. Nilesh Kalyanaraman said. “By slowing the spread over the next few months, more people will be alive and able to get the vaccine when it becomes available. These actions will decrease the stress on our hospitals and keep more people from getting sick.”

Pittman is asking for patience over the next four weeks.

“We understand that this is going to be a burden for our residents none of us wanted to make these decisions,” Pittman said.

“COVID is caused by a respiratory virus, so, not surprisingly, it is spreading faster as we head into winter,” said Dr. Eili Klien, associate professor of emergency medicine at Johns Hopkins Medicine. “The actions that we took in the summer and fall to slow spread are not as effective now that cold weather is here. As hospitals fill with COVID patients, care for all patients will suffer. We know that this virus spreads indoors when people are not wearing masks. If we don’t slow the growth in cases, needless suffering and deaths will occur. With vaccines coming soon, there is a light at the end of the tunnel. We all just need to work together to get through the next few months.”

The county executive announced Thursday that the following new restrictions will take effect Dec. 16 and will last until at least Jan. 13.

RESTAURANTS: The new executive order will restrict restaurants and other food service venues to takeout service or curbside pickup only, like they were in the spring during the initial surge of COVID-19.

RESTAURANT GRANTS: To aid the restaurant industry and its workers, Pittman announced that establishments that received a grant as part of the $10 million Restaurant and Food Service Grant Program will receive an additional payment of up to $7,000 by year’s end.

FEES WAIVED: Pittman also announced that the county would waive the annual restaurant fees due in February and committed $1 million to support Feed Anne Arundel, a partnership of local restaurants, the Anne Arundel County Partnership for Children, Youth and Families, Anne Arundel Connecting Together and the Cal Ripken Sr. Foundation.

“COVID-19 has dramatically impacted local restaurants and Feed Anne Arundel is working hard to keep restaurants open, employees working, and people fed,” said Monica Alvarado, founder of Feed Anne Arundel. “This $1 million commitment from County Executive Pittman will help our restaurants, caterers, and bed and breakfasts continue to serve the community, while also keeping the entire supply chain — employees, vendors, farmers, watermen, delivery drivers, warehouse staff — working, too.”

RETAIL/FITNESS/PERSONAL SERVICES: Retail stores, indoor gyms and fitness centers, personal services establishments (such as nail salons), and casinos will have a reduced maximum capacity of 25%.

RELIGIOUS FACILITIES: Religious Facilities will have maximum capacity reduced to 33%; however, outdoor services for Christmas, Hanukkah or other recognized religious holidays are permitted with a maximum of 250 persons, provided they follow social distancing and other safety protocols.

THEATERS/ENTERTAINMENT: Indoor theaters, performance venues, bingo, bowling alleys, pool halls, roller rinks and indoor ice rinks will be closed. The county previously suspended organized athletics on county fields and facilities on Nov. 20, and Thursday’s announcement suspends all organized sports play or practice, which includes private schools, and school or church gyms.

County restaurateurs call restrictions crushing blow to business

For Nicki Hubers-Hall, owner of Willy’s Kitchen in Ferndale, the county executive’s announcement is a crushing blow.

“It’s heartbreaking, it’s heartbreaking to my staff, it’s heartbreaking to my family,” she said. “I have spent thousands and thousands of dollars to meet these mandates that we’re required to do. We’re not getting any money for this were a low profit margin business,” Hubers-Hall said.

When asked why he’s not enacting statewide restrictions, Gov. Larry Hogan said during a news conference Thursday afternoon the state is taking actions as officials see fit and that he’s not sure why local jurisdictions are closing outdoor dining.

“It’s not something that I think I would have done,” Hogan said. “That is not the №1 source of transmission, by the way. All of our contact tracing data shows the №1 source of transmission is family gatherings … I think fifth on the list is indoor dining. So while it’s important and if we have to take those kind of actions, we will. But right now, I think the latest survey I saw, 69% of the people in our state do not feel safe dining indoors.”

The governor said closing restaurants has an impact on small businesses.

“It is a death sentence for a number of small businesses, so we will take those actions only when we really absolutely deem them to be essential, saving lives and stopping hospitals from overflowing,” Hogan said.

Pittman said the state will offer up to $7,000 per restaurant in grants, but Hubers-Hall is wondering what will happen not only to her business, but her employees.

“I never, in my wildest dreams, thought that we would get shut down again,” Hubers-Hall said.

Pittman said that if after the four weeks conditions are looking better at hospitals, a reopening will begin, but if things are worse, he said he will force the small businesses continue to be limited.

AUSTIN (KXAN) — With federal regulators in a meeting Thursday slated to vote on whether to grant Emergency Use Authorization to the Pfizer-BioNTech COVID-19 vaccine, the possibility of a rollout of the first COVID-19 vaccines in the U.S. feels more tangible than ever.

If the vaccine is approved by the U.S. Food and Drug Administration Thursday, state health leaders have said the first week’s allocation of 224,250 doses of the Pfizer vaccine could be shipped to 109 hospitals in 304 counties as early as next week.

To watch this FDA meeting live, click here and to view the day’s agenda, click here.

Local and state governments have already been planning for the expected approval of the Pfizer and other vaccines, so we already know quite a bit about how the vaccine will be distributed in Texas once it is available.

MORE: COVID-19 vaccine voluntary for UT Austin community for now

How soon could doses reach Texas?

Chris Van Deusen, the Director of Media Relations for the Texas Department of State Health Services (DSHS), said he believes it’s likely the FDA will issue an Emergency Use Authorization for the Pfizer vaccine in the next few days. Whenever that authorization is issued, he said “vaccines could start rolling” 24 hours after that point.

Van Deusen expects within several days, certainly within the week, of the Pfizer vaccine’s approval that it will arrive at Texas healthcare facilities. But he noted in addition to the FDA’s authorization, a Centers for Disease Control and Prevention committee will also have to approve Pfizer’s vaccine before Texas healthcare facilities can start administering it.

Where will the first doses go?

Texas leaders have already made it clear that key healthcare workers will be the first to receive this vaccine.

MORE: Healthcare workers will be first to receive COVID-19 vaccine as early as December, Gov. Abbott says

“I wish we had enough for everyone who wanted to be vaccinated in this first week to be vaccinated, but it’s just not possible,” Van Deusen said.

DSHS released a list of the major healthcare facilities across the state which will receive COVID-19 vaccine doses in the first week the vaccine is available.

DSHS said the vaccine will be shipped on dry ice in a thermal box and that the federal government will provide “one re-charge of dry ice” that should keep the vaccines stable for at least five days, if they are kept at the right temperature.

While initially, the ultra-cold storage requirements of the Pfizer vaccine stirred some concerns about distribution in Texas, Van Deusen said the greatest limiting factor with this vaccine has actually turned out to be the requirement for the size of the orders for the vaccine. He said Thursday the state decided not to restrict any region’s access to this Pfizer vaccine based on regional storage abilities.

IN-DEPTH: No, your ice cream supply won’t be jeopardized by ultra-cold COVID-19 vaccines

The first week of vaccines distributed in Texas will go to medical facilities with at least 975 people on site, as 975 doses is the minimum amount required to receive the Pfizer vaccine right now.

Different Texas hospitals have been allocated different amounts of vaccine doses, and Van Deusen said that is all based on the number of healthcare workers each facility believes it can quickly vaccinate.

What happens next?

While Texas awaits the Pfizer vaccine’s approval from federal regulators, state leaders also expect the approval of the Moderna vaccine to follow soon after.

This initial group of doses, Van Deusen expects, will be “probably the smallest allocation” Texas gets during the vaccine rollout.

“We expect more vaccine will be available in week two [of vaccine distribution], and it will be going to more providers,” he said.

MORE: Texas pharmacies prepare for coronavirus vaccine shipments

There is a larger list of providers in regions around the state, which will receive shipments of the vaccine after the initial group of major hospitals received theirs. But DSHS said they haven’t posted that list yet as the specifics are still being ironed out.

“The Week Two plan is to expand distribution to more facilities and more types of facilities, we don’t have a final list yet, we are working on that now,” he said.

“Looking at things overall, this is really good news,” Van Deusen said. “But this is just the first kind of step in a long process.”

“I think people still need to be patient, it’s going to take months to get the vaccine available for everyone who wants to get it,” he continued. “We need to take those public health steps that we’ve been talking about for so long: wear a mask, stay home where you can.”

Maryland Gov. Larry Hogan on Thursday announced new measures from the state to provide businesses COVID-19 relief funding, but there will not be new statewide restrictions at this time.

The governor started by reviewing the state’s current coronavirus data.

“It is clear that we are experiencing a post-Thanksgiving surge and that the worst days of the pandemic are still ahead of us,” Hogan said.

As of Thursday, Maryland had 1,720 coronavirus patients in need of hospital care, which is a new record high since the pandemic started. The state surpassed a previous high of 1,711 reported on April 30.

There are 416 people in intensive care, which is the highest level since June 6. The governor said 88% of staffed acute beds are occupied, 87% of ICU beds are occupied and 143 surge beds are currently in use as of Thursday.

And Maryland continues to see a rise in new cases. Thursday marks the 10th straight day of more than 2,000 confirmed cases as 3,202 new cases were added — the second-highest single day increase — in the last day and 49 more Marylanders died from COVID-19 complications.

See the data in our interactive map and graphs

Governor announces COVID-19 relief for businesses

ECONOMIC RELIEF UPDATE: More than $215 million of Maryland’s $500 million economic relief package has now been provided through the COVID-19 Emergency Relief Fund to more than 16,000 businesses across the state.

Hogan said $50 million has been distributed to all 24 jurisdictions for the state’s Restaurant Relief Fund to support both indoor and outdoor dining. More than $40 million has been directed to more than 1,800 nonprofit organizations.

Nearly $25 million has been awarded through the state’s Layoff Aversion Fund to more than 1,000 small businesses saving nearly 20,000 Maryland jobs, and $8 million is being directed to entities that rely on tourism and visitors.

“Today, we are immediately taking additional state actions to help businesses struggling to hang on to avoid the prospect of more layoffs right before Christmas or being forced to go out of business in a matter of weeks,” Hogan said.

Watch the governor’s news conference in its entirety:

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EMERGENCY TAX RELIEF FOR SMALL BUSINESSES: The governor signed an executive order intended to protect Maryland businesses from sudden or substantial increases in their unemployment taxes.

LOAN FORGIVENESS: In March, the state provided $75 million in emergency loans to Maryland businesses. The governor is directing the Maryland Department of Commerce to forgive the entire $75 million in emergency loan debt. The loans will be converted to grants, which will not need to be repaid.

The Maryland Chamber of Commerce released a statement after the governor’s news conference, saying: “We are continually grateful for the leadership of Gov. Hogan and the Maryland Departments of Commerce and Labor, who remain laser-focused on addressing the financial and operational challenges faced by Maryland businesses.

“We have known since the early days of the pandemic that employers would ultimately confront increases in unemployment taxes. The governor’s announcement today represents a tremendous step in mitigating the impact of increasing costs on Maryland’s businesses. We look forward to continuing to work together on solutions that blunt the economic impact of COVID-19 on our state’s job creators.”

AFFORDABLE HOUSING: The state will be funding $25 million in low-income housing tax credit projects, which will allow and promote the construction of 2,000 units of high-quality affordable housing — the largest number of units the state has ever financed.

The governor announced $12 million through the Rental Housing Works Program, which will spur even more projects and create jobs for construction workers across the state. In addition to these state actions, the governor urged county leaders to match these relief dollars and to push out their remaining coronavirus relief funding into the economy.

DIABETES: The governor announced $94 million in new grants and investments to help treat Marylanders with diabetes, which is the №1 comorbidity for serious illness from COVID-19.

YOUTH AND VICTIM SERVICES: $10 million in investments will go toward funding for personal protective equipment and protective barriers for the 34 district court locations, rapid testing equipment for the Maryland State Police and additional resources to increase internet access for Baltimore City youth.

Local officials announce stricter COVID-19 restrictions

Local officials started this week to enact stricter restrictions. New restrictions will take effect Friday in Baltimore City and Wednesday in Anne Arundel County — both jurisdictions are prohibiting in-person dining at restaurants.

Prince George’s County is one of Maryland’s jurisdictions hardest hit by the coronavirus. The county currently has a positivity rate of 10.1%. As such, county officials said they will shut down only indoor dining starting at 5 p.m. Wednesday. Outdoor dining can still operate in the county at 50% capacity. Under the county’s new restrictions, casinos and retail businesses cannot exceed 25% capacity.

Hogan said the state is monitoring the data: “We are continuing to monitor all of our data metrics to determine what additional statewide mitigation actions may be required.”

When asked why he’s not enacting statewide restrictions, Hogan said the state is taking action as officials see fit and that he’s not sure why local jurisdictions are closing outdoor dining.

The governor said closing restaurants has an impact on small businesses.

A spokesman for Baltimore County sent a statement to 11 News, saying: “County officials are continuing to evaluate key metrics, remain in close consultation with hospital leaders and we remain prepared to take additional actions to protect public health. We continue to urge county residents — and all Marylanders — to follow the science: wear a mask, keep social distancing and take every precaution to keep our loved ones and neighbors safe this holiday season.”

Harford County will not be planning further restrictions at this time. County Executive Barry Glassman sent 11 News a statement, saying: “I continue to monitor our numbers daily, but I am not planning further restrictions at this time. Our best defense until we get a vaccine is for each of us to take personal responsibility for staying safe and protecting others.”

Biden’s election Six GOP-led states join Texas bid to overturn

Rare Adverse Reactions

Efficacy Questions

Impact of Emergency Authorization

County restaurateurs call restrictions crushing blow to business

How soon could doses reach Texas?

Where will the first doses go?

What happens next?

Governor announces COVID-19 relief for businesses

Local officials announce stricter COVID-19 restrictions

Written by Calobiv