FDA gives emergency OK to Pfizer and BioNTech vaccine

by Bailey Amber
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Red seal and imprint "FDA APPROVED" on white surface. FDA - Food and Drug Administration is a federal agency of the United States Department of Health and Human Services.

Under public pressure from President Donald Trump, the U.S. Food and Drug Administration on Friday night approved the country’s first Covid-19 vaccine, paving the way for its distribution as early as the weekend.

The emergency approval follows the vaccine’s endorsement Thursday by an outside advisory panel to the FDA and comes as the Covid-19 pandemic continues to cut a deadly swath through the U.S.

The move, though, sets up another difficult chapter in the fight against Covid-19: distributing the vaccine to millions of Americans, starting with health care workers and nursing-home residents. The vaccine was developed in record time by New York-based drug maker Pfizer and a German partner, BioNTech

The initial shipment will include 2.9 million doses. Overall, Pfizer and BioNTech are expected to provide 100 million doses of the vaccine over the next few months, enough to immunize 50 million people. It’s still unclear how many doses will be available after that, with the companies and the government reportedly at odds over future deliveries

Given the challenges ahead, the FDA’s approval was cause for measured celebration.

“While a commercially available Covid-19 vaccine is an important milestone on the road to recovery, mass vaccination of the American people represents a monumental effort unlike any we’ve undertaken before,” Andy Brailo, chief customer officer of health care services company Premier Inc., said in a statement. “The distribution and administration of Covid-19 vaccines to the public will be the supply chain and population health challenge of the pandemic.”

It will also represent a public relations challenge, as events leading up to the FDA’s approval renewed fears that the process was being politicized, potentially sowing distrust

In a Friday morning tweet, President Trump publicly lobbied the FDA to act. “Stop playing games and start saving lives!!!” the president wrote. Then, the White House reportedly threatened FDA Commissioner Stephen Hahn to approve the vaccine on Friday or resign. The FDA reportedly had been planning to act Saturday.

Trump announced the approval with a video message on Twitter.

“Today our nation has achieved a medical miracle,” the president said. “We have delivered a safe and effective vaccine in just nine months. This is one of the greatest scientific accomplishments in history.”

In a statement of his own, Hahn played up the scientific rigor underlying the vaccine’s approval.

“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” he said in a statement. “The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”

But while the vaccine’s benefits have been judged to outweigh its risks, there are some things to be considered. 

Sheba Medical Center’s Dr. Noam Tau, the lead researcher of a recent study assessing the safety of all U.S.-approved vaccines over a twenty year period, believes that no vaccine trial is perfect, and Pfizer’s Phase 3 trials has issues and shortcomings — for instance, the vaccine wasn’t sufficiently tested on some minorities (such as African Americans and Native Americans); not tested on “special populations” (pregnant and lactating women, immunocompromised, patients of 75, children under 16 years old). Further, he added in an email that the endpoint was assessed for symptomatic Covid-19 infection, for which it is 95% efficacious. Efficacy for asymptomatic infections was not tested. These shortcomings should be kept in mind when deciding who should be vaccinated first and in deciding on which populations should be studied next.

Pfizer and BioNTech began a two-year clinical trial of the vaccine in July and announced interim results last month showing it was 90% effective. That was later revised upwards to 95%.

Not surprisingly, the FDA advisory panel questioned whether enough data had been collected on the vaccine’s impact on 16- and 17-year-olds and on pregnant women. Members also questioned whether the vaccine protected against asymptomatic infection, a main channel for spreading Covid-19.

The panel also noted allergic reactions in two British people who had received shots. Most reactions, though, are mild and similar to what happens with other vaccines.

The Pfizer/BioNTech vaccine relies on a relatively new technology known as messenger RNA, which essentially triggers an immune response to Covid-19 without having to inject any of the virus itself. It is given in a series of two shots, 21 days apart.

The distribution challenge begins with the extremely cold temperatures at which the vaccine must be kept: between -60 and -80 degrees Celsius. Questions also have arisen over the medical staff needed to administer vaccines, given the demands of caring for people already sick with Covid-19.

State and health systems have been bracing for the distribution effort, guided in part by recommendations from the U.S. Centers for Disease Control and Prevention.

“While we along with public health officials throughout the country spent countless hours preparing, this mission is fraught with significant challenges that go well beyond just transporting the vaccine from point a to point b,” Pennsylvania Health Secretary Dr. Rachel Levine testified Thursday during a Senate hearing on vaccine transport.

Funding, equity and coordination among the public and private sectors as among the challenges ahead, Levine said, “all confounded by the lack of a coordinated communication strategy to promote confidence in the safety and efficacy of Covid-19 vaccines.”

Next week, an FDA panel will evaluate data from Moderna’s mRNA Covid-19 vaccine. 

“We should remember — no one vaccine, and no one manufacturer will be enough for the US, and definitely not for the whole world’s supply of vaccines,” Dr. Tau said in an email. “This means that the approval of the EUA for Pfizer’s vaccine is not the beginning of the end, but merely an important step towards the end of the beginning of the pandemic. There is a long way to go yet before we are out of the woods, both locally in the US and globally.

Photo: Waldemarus, Getty Images

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