- The Washington Times - Tuesday, December 8, 2020

President Trump took a victory lap at his White House vaccine summit Tuesday, but the man of the hour is a Food and Drug Administration official few Americans know about.

“Dr. Peter Marks,” President Trump said in a roll call of his Operation Warp Speed roster. “Thank you.”

Dr. Marks, director of the Center for Biologics Evaluation and Research, will play a pivotal role in deciding whether the Pfizer vaccine for COVID-19 is safe and effective enough for distribution in the U.S., possibly by the weekend.

His team is poring over data submitted by Pfizer, rather than taking the company’s word for it, ahead of a Thursday meeting and vote with outside advisers that could pave the way for emergency approval and the first vaccinations of health care workers and long-term-care residents.

The White House pulled Dr. Marks into the summit Tuesday to build confidence in Operation Warp Speed, the initiative that developed vaccines at a record pace and gave Mr. Trump a win during a critical stretch of the pandemic.



“Corners were not cut here,” Dr. Marks said from the stage at the White House South Court Auditorium.

“We don’t just take the data that’s handed to us from companies and look at it. We actually take the data listings, the raw data that gets sent to us and do analyses ourselves on that,” Dr. Marks said. “Sometimes we learn things that the manufacturers didn’t even know about their own vaccines, by doing our analyses.”

Mr. Trump signaled that he won’t wait much longer for approval. He wants the FDA to grant Pfizer an emergency use authorization after Britain on Tuesday became the first Western nation to kick off its vaccination campaign.

“We’ve got to get it moving,” Mr. Trump said, noting that Moderna’s request for approval is right behind Pfizer’s. “Hopefully, that will go very quickly.”

Dr. Marks, who joined the FDA in 2012 and rose to become director of the Center for Biologics Evaluation and Research in 2016, hasn’t been a fixture on the White House podium or in the Rose Garden during the pandemic. But experts say he has built confidence in the regulatory process during a campaign year marked by concerns of political meddling.

“Peter has been a key figure in helping to preserve the integrity of the FDA review and [the] decision to release vaccine under [emergency use authorization],” said Peter Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine.

Lawrence O. Gostin, a professor of health law at Georgetown University, said Dr. Marks is a “highly respected scientist” and “the nation is in safe, capable hands with his leadership.”

The Pfizer review is just the start. Operation Warp Speed hedged its bets by developing vaccines under three platforms. Two drugmakers worked within each category, for six companies in total.

Vaccines from Pfizer and Moderna, which used messenger RNA, are ahead of the others and are on track for approval by Christmas.

AstraZeneca and Johnson & Johnson are steeped in late-stage trials of their adenovirus vaccines. J&J is developing a single-dose vaccine — other candidates require two doses — and could apply for emergency use by January or early February, said Moncef Slaoui, the scientific adviser for Operation Warp Speed.

Novavax and a partnership, Sanofi-GlaxoSmithKline, are using recombinant proteins in their vaccines and may apply to the FDA in the first half of next year.

“We have two in the hand, two close by and two to come,” Mr. Slaoui said.

Mr. Trump highlighted the mix of candidates as the White House refuted claims that it balked at a chance to buy more Pfizer doses.

“We have some big ones we’re going to be announcing very soon,” Mr. Trump said. “Johnson & Johnson and others. They’re all coming in, and they’re coming in very quickly.”

The president said he is willing to invoke the Defense Production Act to procure additional doses of vaccine, though “we don’t think it will be necessary.”

Mr. Trump also signed an executive order that says the supply of U.S.-secured doses must go to Americans who want the vaccine before they are sent to countries abroad.

The president took credit for efforts to produce ventilators and testing equipment to fight COVID-19 but said little about the swirling crisis that is killing more than 2,000 people per day, based on seven-day rolling averages. More than 100,000 people are hospitalized for COVID-19 across the country, portending more deaths. The disease has killed more than 285,000 Americans and sickened 15 million.

Critics have faulted Mr. Trump’s conflicting advice on mask-wearing and crowds and say he should be focused on the pandemic instead of vote tallies showing his election loss to Democrat Joseph R. Biden. During the campaign, he told packed rallies that the U.S. was “rounding the turn” even as the situation worsened.

Responding to questions about the crisis, Mr. Trump said the vaccine was his “goal” and that some people have built-in immunity. He also defended White House Christmas parties by saying attendance has been cut and many guests wear masks.

Pfizer and Moderna did not send representatives to the White House event despite being the front-runners.

The White House said it planned to include the companies but then decided it would be inappropriate because Dr. Marks, a regulator, is reviewing their requests for emergency approval.

Paul Mango, a deputy chief of staff at the Department of Health and Human Services, said Dr. Marks wanted to keep working Tuesday but “we thought it was much more important for the American people to hear from him briefly about the rigorous process, the exacting process, that he is taking his team through to evaluate these [vaccines].”

“When he’s done, he’s going to head right back out to the FDA,” Mr. Mango said in introducing Dr. Marks.

The FDA on Tuesday released data from Pfizer showing the vaccine reduced the risk of COVID-19 after the first dose. Regulators also said the shots were “highly effective” at least seven days after the second dose regardless of age, weight or race.

The Vaccines and Related Biological Products Advisory Committee will discuss Pfizer’s data Thursday and considerations for various populations before voting on whether the vaccine deserves emergency approval.

The vaccination campaign is expected to begin within 24 hours of the FDA’s green light.

The United Kingdom began its immunization campaign Tuesday with a 90-year-old grandmother in central England.

Margaret Keenan, of Coventry, became an instant celebrity by being the first person to receive the Pfizer vaccine outside of trials.

Donning a blue “Merry Christmas” shirt with a penguin on it, Ms. Keenan said she felt “so privileged” to be first in line and was looking forward to spending time with family in the new year.

She competed for attention with the second person in line, who was named William Shakespeare.

HHS told The Washington Times that Operation Warp Speed leaders “have communicated with their counterparts in the U.K. and will continue to share information related to the strides that we respectively make in developing, manufacturing and distributing COVID-19 treatments and vaccines.”

U.S. officials say they need at least 70% of the population to take the vaccine to develop the type of herd immunity that will get transmission of the virus to manageable levels next year.

Army Gen. Gustave Perna, who is guiding logistics for the White House, said he will tell his mother and sons to take the vaccine once it is available, as Operation Warp Speed tries to break through hesitancy across the nation.

“We can do this,” he said, “if we do it together.”

Sign up for Daily Newsletters

Manage Newsletters

Copyright © 2021 The Washington Times, LLC. Click here for reprint permission.

Please read our comment policy before commenting.

 

Click to Read More and View Comments

Click to Hide