August 2, 2021 US coronavirus news

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the US Food and Drug Administration, said in an interview with the Washington Post Friday that the center will work towards getting Pfizer’s Covid-19 vaccine full FDA approval as quickly as possible. 

Marks also explained the difference between what is required for emergency use authorization, which all the vaccines currently have, and full approval, saying that “in terms of pages to review the change is an order of magnitude. It’s going from tens of thousands of pages, to hundreds of thousands of pages.” 

Manufacturing for a full approval also has to be “much more well-described and detailed” than for an EUA, he said, as well as additional inspections of facilities that have to be done. 

Marks said that what is normally done for biologic license applications is to have six months of follow-up data on those who received the vaccine in clinical trials. He said that the data from the millions of people who have gotten the vaccine but were not part of trials can’t be used because “we don’t follow all those millions of people in the same manner that we are able to follow people who are enrolled in clinical trials.”

When it comes to manufacturing issues being looked at by the FDA, Marks said “The whole process has to work, there have to be appropriate controls and the testing that has to be done,” adding that it isn’t just the vaccine drug substance, but also how it is made into a product and put into vials. The whole process is inspected and then the FDA has to make sure that the end product is ready to be released.

He said that each vaccine review is unique, but the FDA aims to complete priority reviews within eight months of receiving and application and standard reviews within 12 months. 

Department of Homeland Security Secretary Alejandro Mayorkas said Monday misinformation is in part to blame for the Covid-19 vaccine reticence that exists among DHS employees.

The department is working with tech companies to strengthen legitimate use of social media platforms and prevent harm from occurring, Mayorkas said, when pressed on combating disinformation. 

DHS, which has more than 240,000 employees, kicked off a program in January to vaccinate employees.

The effort started with 2% of the DHS workforce and has "made leaps and bounds and success," Mayorkas said, but did not provide an update. 

"We cannot overstate not only to our own workforce, but to the American public, the absolute imperative, of getting vaccinated," he said. 

As of last week, the department is requiring all federal employees, contractors, and visitors, regardless of vaccination status, to wear a mask inside all DHS workspaces and federal buildings, according to a memo sent to the workforce.

The memo, sent late Tuesday night from DHS Deputy Under Secretary for Management Randolph “Tex" Alles, urged employees to get vaccinated and get tested for Covid-19 if they experience symptoms. 

West Virginia Gov. Jim Justice announced Monday that the nation's first statewide Covid-19 antibody study has launched last Thursday. 

The program, called the "Booster Battlefield Assessment," asks for volunteers who are fully vaccinated and age 60 or older to be tested for antibodies. 

The results will be sent to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), along with "the vaccine manufacturers," Justice said. He didn't confirm which vaccine manufacturers in the US would receive the data.

It will help "assist in determining if a third dose of vaccine is best for our citizens over 60 who have had their first vaccine (that) is six months old," Justice said.

Justice said, "We're going to move as quickly as we possibly can to go to our nursing homes, or on a voluntary basis, anybody that's aged 60 and above that absolutely wants to get their antibodies tested."

Justice said that it is the first statewide program to test and measure antibody levels. "West Virginia has led the way … Little old West Virginia," he said.

The state will work with West Virginia University, Marshall University and the West Virginia Department of Health and Human Resources (DHHR) to run the program. 

West Virginia Health Secretary Bill Crouch said those involved in the program are working "to get this started immediately. We should be drawing samples within the next couple of days."

Since it is a research project, the program will be funded mostly by the state, Crouch said. 

At the news conference, Justice said he wouldn't mandate vaccines or masks, but continued to urge people to get vaccinated. 

"Don't be too late. Get your vaccine. Not only will it make you feel better and put you at ease, but it'll put your family at ease, all your loved ones at ease, and it will absolutely make it to where you are really part of the solution," he said. "You're part of the solution to get this thing dead and killed and gone forever."

Germany will begin offering Covid-19 vaccine booster shots to people at risk starting September, Health Minister Jens Spahn said in a statement on Monday.

"With the option of a booster vaccination in September, we want to provide the best possible protection for the groups particularly at risk in the fall and winter. Because for them, the risk of a decline in vaccination protection is the greatest," Spahn said.

Germany’s health ministry said the booster shots given will be “one of the two mRNA vaccines." The mRNA vaccines currently approved by the European Medicines Agency (EMA) are Pfizer-BioNTech and Moderna.

Some more context: In July, Germany's Standing Committee on Vaccination (STIKO) said people who receive a first dose of the Oxford-AstraZeneca vaccine "should get an mRNA vaccine as their second dose, regardless of their age," in what was the world’s strongest recommendation for the mixing of Covid-19 vaccines on efficacy grounds. German Chancellor Angela Merkel helped pave the way for mixed vaccine use when she received the Moderna shot in June as her second dose following a first dose of the AstraZeneca vaccine. STIKO said in July that "current study results" show that the immune response generated after a mixed dose vaccination "is clearly superior."

Spahn also announced Monday that children aged 12 to 17 years old who want to be vaccinated can be "after being informed by a doctor." The announcement came after he met with Germany's 16 regional health ministers.

He said officials in Germany's 16 states "also want to make a vaccination offer to this age group as low-threshold as possible" and said the decision is in line with the recommendations of STIKO.

STIKO previously announced in June that it only officially recommended the shot for 12- to 17-year-olds if they had pre-existing conditions or lived with people at high risk from Covid.

Just over 52% of German citizens are fully vaccinated and almost 62% have received at least one shot, according to the Robert Koch Institute, Germany’s disease and control center.

Equinox Group announced Monday it will require members, riders and workers to show one-time proof of vaccination to enter its Equinox fitness clubs and SoulCycle studios in New York City.

The change, which will take effect in early September, will also apply to the company’s corporate offices.

Equinox said proof of vaccination status can be provided by showing a physical vaccine card, a photo of the card, or digital vaccine cards. The company said it will work with members, riders and employees who require medical or religious accommodations.

Equinox cited a recent survey it conducted that found 96% of its responding fitness club members and 89% of employees indicated they are vaccinated against Covid-19.

A North Carolina charter school will now require masks in school after more than 150 students and staff members have been quarantined following the first week of school. 

Union Academy Charter School in Monroe, North Carolina, announced it has 14 active cases of Covid-19 detected since school started last Monday. The school is on a modified year-round calendar.

Students returned to school today with the universal masking policy in place, and without any incidents, according to the statement.

"UA looks forward to a time in the near future when masks and quarantines will be unnecessary," the statement said.

The White House's Covid-19 data director, Cyrus Shahpar, says on Twitter the US has hit 70% of adults with at least one dose of the coronavirus vaccine.

This is the goal the administration originally set for July 4, so it is roughly a month behind that deadline.

Today’s vaccination numbers have not yet updated on the CDC website, so people will not see this reflected yet if they look on the dashboard.

A senior administration official told CNN they believe there are governors in the country who are putting their “political interests” ahead of public health in getting their citizens vaccinated.

The briefing, which was held just with journalists from CNN, is a sign itself that the White House is attempting to course-correct messaging around Covid-19 after the the US Centers for Disease Control and Prevention sparked confusion when it changed mask recommendations for the fully vaccinated.

Asked about the White House’s mistakes in messaging and what they plan to do, an official pushed back on the claim but said they will continue to use everything in their power to push vaccines — adding the White House needs to change as the data changes.

The official reiterated a national mandate for all Americans to be vaccinated is not under consideration, saying the White House has determined it is not within Biden's scope of power as President.

But the official did not rule out a stricter mandate on federal workers that goes beyond the announcement Biden made last week that federal employees must attest to being vaccinated or face stringent mitigation measures. That was only a first step, the official said, designed to make life more difficult for those federal workers who decline to be vaccinated. Biden has asked his team to take a hard look at what authorities he has as it relates to federal workers, and the White House continues to look at all of those options, including within different subsets of the federal government.

A senior administration official also told CNN that the CDC is now tracking more than just hospitalizations in breakthrough cases, despite health officials previously telling CNN they were not tracking cases that don’t result in hospitalization or death. This official says the CDC is using a vast network of health care workers, nursing homes and other facilities to obtain information on breakthrough cases. The official added they are having "constant dialogue" with other countries on tracking these kinds of infections as well.

This senior official declined to provide a more specific number on how many vaccinated people they have found are contributing to the spread of Covid-19. They reiterated that they know it's possible, but still believe those people with breakthrough cases are less likely to spread it than those who are unvaccinated.

Asked about any concerns about children returning to school this fall, a senior administration official said the White House is confident they’ll be able to contain cases in school and expect to focus more this week on precautions that schools can take. The administration official was clear they don't want schools to have to contemplate returning to virtual learning.

On children wearing masks, the official added they don’t want children to be bullied for wearing masks in school, but said it's more important kids not be exposed to the virus from others not wearing masks.

CNN's Kaitlan Collins and Kevin Liptak contributed to this report.

In rescinding its short-lived indoor mask mandate, Pensacola State College is adopting a new Covid-19 absence policy.

“Even though the Governor’s recent executive order regarding face masks at this time only pertains to K-12, PSC will not require face coverings indoors but does strongly encourage face coverings indoors particularly for all unvaccinated persons,” a message from college president Ed Meadows says on the college’s website. 

The college had announced on July 28 they would be implementing an indoor mask mandate.

That message also announced a new absence policy that would have a significant effect on anyone that is unvaccinated and acquires Covid-19. 

If a student accrues enough unexcused absences, Pensacola State College policy indicates that they could be withdrawn from the class.