- The Washington Times - Monday, August 23, 2021

Hospitals, governors and the military wasted little time Monday in requiring their workers to roll up their sleeves after the Food and Drug Administration fully approved a COVID-19 vaccine for the first time.

Hours after the Pfizer-BioNTech shots received licensure, the Pentagon confirmed that it will follow through with Defense Secretary Lloyd Austin’s push to mandate the shots for more than 1 million active-duty troops.

CoxHealth, a hospital system in Missouri walloped by the delta variant of the coronavirus, said workers must get their first dose by Oct. 15. CEO Steven Edwards tied the mandate directly to the FDA‘s approval and said “careful consideration will be given to allow medical and religious exemptions.”

New York Mayor Bill de Blasio said Monday that all public education employees, including custodians as well as teachers, must receive at least one dose of a COVID-19 vaccine by Sept. 27. New Jersey Gov. Phil Murphy said school workers and other public employees in his state must get vaccinated or face weekly testing. It was a massive expansion of the mandate he imposed on health care workers.

President Biden applauded employers for requiring the shots and told other companies to follow suit.



He characterized the FDA decision as a watershed moment in the pandemic fight and pleaded with nearly 90 million eligible, yet unvaccinated, Americans to schedule their first shots. Roughly 3 in 10 unvaccinated people told the Kaiser Family Foundation that they would be more likely to take a vaccine if it was fully approved.

“The moment you’ve been waiting for is here. It’s time for you to get get your vaccination. Get it today,” Mr. Biden said. “Those who’ve been waiting for full approval should go get your shot now.”

Regulators fully approved the Pfizer-BioNTech vaccine for those 16 and older. Children ages 12 to 15 can receive the shots under an emergency use authorization that has been in place for them since May.

The FDA said its decision to license the Pfizer vaccine was based on data that the drugmaker provided from more than 40,000 trial participants in the U.S., Europe, Turkey, South Africa and South America. Regulators said the vaccine was 91% effective against COVID-19 disease in these participants, a slight drop from the 95% observed before the emergency approval late last year.

The review took a deep dive into follow-up data from clinical trials and inspections of manufacturing sites. The vaccine will be the same one distributed under the emergency use authorization, with two doses given 21 days apart. Pfizer plans to market the vaccine under the brand name Comirnaty.

The FDA announced its decision during a surge of coronavirus infections after a hopeful reprieve in late spring and early summer. More than 1,000 people a day in the U.S. are dying from COVID-19, a level far below the 3,000-plus daily death rate in January but a worrisome trend that could upend Mr. Biden‘s recovery plans.

Roughly 51% of the U.S. population is fully vaccinated, a level far below the 90% or so that scientists are targeting to fully wrangle the virus.

“For anybody who does have doubts, this [approval] should help overcome it,” said former FDA Commissioner Mark McClellan, who directs the Duke-Margolis Center for Health Policy.

“I do think we now have very clear evidence that some of the misinformation out there — like the vaccine can cause fertility issues or can cause COVID or things like that — are just not there in the data. On the other hand, the effectiveness is,” he said.

Dr. Janet Woodcock, the acting FDA commissioner, said the agency worked under “an unprecedented timeline, given the volume of the review and meticulousness with which it was done,” but she insisted that regulators did not sacrifice their standards.

Sen. Ron Johnson, Wisconsin Republican, said the process appeared rushed for political purposes and sidestepped outside advisers.

“Expediting the approval process for the COVID-19 vaccine appears to primarily serve the political goal of imposing and enforcing vaccine mandates,” Mr. Johnson said in an email to The Washington Times. “Our federal health agencies have not been forthright with the public about how these life-altering decisions have been made or what science and data they are based upon. This lack of transparency is unacceptable. The American people deserve full and accurate information so that they make up their own minds regarding vaccination.”

Approval is expected to lead to a sudden increase in the number of businesses and venues willing to condition employment or entry on vaccination.

The University of Minnesota said it will send an email message telling students how to produce proof of vaccination now that federal approval is in hand. MedStar Health, a large health care system in the Baltimore-Washington region, said in June that it would require its workforce to get vaccines once the FDA gave full approval.

United Airlines said its employees would have to get vaccinated within five weeks of approval, which puts the deadline in mid-September.

“The trajectory of the pandemic in the U.S. is almost entirely determined by the rates of vaccination in the U.S., so any increase in vaccine rates will be impactful,” said Dr. Amesh Adalja, a senior scholar for the Johns Hopkins Center for Health Security.

The Justice Department and many lawyers say employers who required the shots under the emergency approval are on solid legal ground. Even so, some employers didn’t want to risk messy litigation or cause upheaval in their workplaces.

The COVID-19 vaccines were developed in record time under the Trump administration’s Operation Warp Speed. The coronavirus was first detected in December 2019, and COVID-19 shots were getting into American arms before Christmas 2020.

Pfizer was the first COVID-19 vaccine maker to receive emergency approval. Moderna followed. Both versions use a messenger-RNA technology that teaches the body how to recognize and attack the spike protein of the virus.

“The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into — nor does it alter — an individual’s genetic material,” said the FDA, hoping to debunk a common myth about the vaccine.

The messenger-RNA shots have been shown to be over 90% effective in staving off severe illness and hospitalization from COVID-19, even in the face of the delta variant.

However, protection against any infection appears to have weakened against delta, and some fear that the immune response wanes eight months after the second dose.

A prominent study from the Centers for Disease Control and Prevention found the vaccines were 74.7% effective against infection among nursing home residents early in the vaccination program, from March to May, but effectiveness declined significantly to 53.1% when the delta variant became rampant in June and July.

A Yale Medicine study found that the one-shot Johnson & Johnson vaccine, which uses adenovirus technology, is up to 71% effective against hospitalization from the delta variant and up to 95% against death.

Amid new challenges for the nation and Mr. Biden‘s response, some are worried about regulators’ due diligence. Mr. Johnson said the rush to full approval was politically motivated.

“The observational phases of FDA approval take time because there is no substitute for time in detecting and determining possible long-term harm,” the senator wrote to major health agencies late Sunday.

He also found it odd that a panel of outside advisers, the Vaccines and Related Biological Products Advisory Committee, did not meet to discuss licensure, adverse reactions and deaths that might have been linked to vaccinations.

The FDA said it held a general meeting on the approval process for COVID-19 vaccines in October.

FDA also has held meetings of the VRBPAC on all three COVID-19 vaccines authorized for emergency use, and does not believe a meeting is needed related to this biologics license application (BLA),” the agency said. “If the agency had any questions or concerns that required input from the advisory committee members, we would have scheduled a meeting to discuss.”

Other congressional Republicans focused on what FDA approval will mean for the popularity of the shots.

“This approval will build more confidence and trust in the vaccines, which are safe and highly effective at preventing severe illness, hospitalizations, and death from COVID-19,” said Rep. Cathy McMorris Rodgers of Washington and other senior Republicans on the House Energy and Commerce Committee.

“Life under this pandemic has been full of fear — fear of the unknown, isolation, and uncertainty. What gave us hope from the beginning was the promise of American ingenuity and innovation. The COVID-19 vaccines, made possible by President Trump’s historic partnership with the private sector, turned that hope into a reality,” the Republican lawmakers said.

Democratic allies of Mr. Biden pointed to stories of unvaccinated people expressing regret from their hospital beds.

“The FDA‘s full approval of a coronavirus vaccine shows Americans can have full confidence in the safety and effectiveness of a vaccine that has been painstakingly studied and reviewed,” said House Speaker Nancy Pelosi, California Democrat. “Every day, we are seeing the tragedy of unvaccinated Americans struggling to breathe in hospital beds, sending heartbreaking messages to their loved ones to get vaccinated before it’s too late.”

Children younger than 12 are not eligible for a COVID-19 vaccine. Dr. Woodcock warned against using the approved vaccine “off label” for young children and said clinical trials on that group underway.

“We don’t have the proper dose, and we don’t have the safety data,” Dr. Woodcock said. “They are not just small adults.”

Moderna is seeking full approval from the FDA and is poised to follow Pfizer in receiving a license this fall. Still, Dr. Peter Marks, director of the FDA‘s center for biologics evaluation and research, declined to estimate a timeline.

Johnson & Johnson got a later start in its rollout and has not yet applied for full approval.

The FDA, citing fears of waning immunity, is expected to review a separate plan in the coming weeks to provide booster shots of the Pfizer and Moderna vaccines to people who received their second doses eight months earlier.

Mr. Biden said his administration is ready to deliver boosters the week of Sept. 20, pending regulatory signoff, though global health officials are upset that wealthy nations are giving third doses before much of the world gets initial shots.

The World Health Organization called Monday for a two-month pause on booster shots because the vaccines are needed to reduce inequality around the globe and thwart the emergence of new variants.

Shen Wu Tan contributed to this report.

• Tom Howell Jr. can be reached at thowell@washingtontimes.com.

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