Pfizer COVID Vaccine Days Away From Approval

December 11, 2020
Frank Diamond

An advisory panel to the FDA voted 17-4, with 1 abstention, to tell the FDA to approve the Pfizer/BioNTech COVID-19 vaccine. US Health and Human Services secretary Alex Azar says that approval may come in days.

It might happen in a couple of days. That’s how far away we are to getting a COVID-19 vaccine approved for use in the United States. A panel of experts yesterday voted to tell the US Food and Drug Administration (FDA) that that agency should grant emergency use authorization, an EUA, for the COVID-19 vaccine developed by Pfizer and BioNTech. The panel examined phase 3 data on BNT162b2, a two-dose messenger RNA (mRNA) vaccine.

US Health and Human Services secretary Alex Azar told ABC news that the FDA intends to tell Pfizer that the FDA will follow the panel's advice and proceed with authorization. Azar said that the FDA needs more information so that it can tell doctors how to prescribe the vaccine properly. And, in Azar’s words, that should happen in a couple of days.

The panel's approval will not come without controversy. As Infection Control Today®’s sister publication, Contagion reports, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), at the end of a long day of discussion, debate and data presentations (which Contagion live-streamed), voted 17-4 with 1 abstention to approve the drug and then “adjourned the meeting immediately following the announced vote.”

Perhaps the panel will release more details about the reasoning behind its decision today, because some portion of the public will need to be convinced to get the vaccine, and those 4 nay votes and the 1 abstention might come back to impede those who need to do the convincing .

The most intense discussions revolved around just what effect the vaccine might have on 16- and 17-year olds, with some panel members voicing concern that there just wasn’t enough data to support giving the vaccine to that age group, and arguing that they should not be given the vaccine.

As Hayley Gans, a professor of pediatrics at Stanford University, put it to STAT: “I would support not including them.” (Gans, though, seems to have been persuaded otherwise as she did vote to grant the EUA.)

Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia, also voted to approve. “We have clear evidence of a benefit. All we have on the other side is theoretical risk.”

Offit did voice some reservations about another group: pregnant women. He told CNN that pregnant women should not get the vaccine until more data are available. “However, as shown in this trial, whenever you do any sort of large clinical trial, invariably you do get pregnant women because women don’t find out they're pregnant until after they’ve gotten one or two doses,” Offit told CNN. “So, there were about two dozen women in this trial that were pregnant and there doesn't appear to be any harmful effects on them, but their babies haven’t been born yet to find out.” About 40,000 people participated in the clinical trial.

The vaccine debate comes as COVID-19’s path of destruction through society and the healthcare system grows. Yesterday, there were 203,304 new cases of COVID reported, according to Johns Hopkins University. That’s the second highest case count since the pandemic began. There have been 15.7 million confirmed cases of COVID-19 in the United States since the pandemic began. And the 2923 deaths recorded yesterday, brings to total death count to about 293,000.

Many see the vaccines—Moderna also has an EUA request before the FDA—as a light at the end of the tunnel. Problem is, as experts have been telling ICT®, it’s a long tunnel. The vaccines might not have any meaningful impact until sometime next year and that’s if enough people get vaccinated.

Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, told CNN that the country could get back to normal next summer or fall if—and this is a crucial “if”—everybody gets the vaccine. “It depends how quickly and how many people want to get vaccinated,” Fauci said.

Kevin Kavanagh, MD, points out in an article on ICT®’s website that “the Pfizer/BioNTech vaccine is in short supply. The lion’s share of the doses are not expected to be delivered to the United States until late June or July, 2021. Moderna appears to have more available vaccines but the exact delivery dates are unknown.”

As the discussion yesterday by the FDA advisory panel underscored, there’s also some concern that the side effects of a vaccine might keep people from coming back for the second dose, something that sometimes occurs with the two-dose shingles vaccine. A nurse who participated in a Pfizer/BioNTech vaccine trial wrote about some adverse reactions to the second dose in an article in JAMA Network. The lesson Kristen R. Choi, PhD, RN, took from her experience might not be the same lesson that patients will absorb. Choi argues that education will be a crucial part of vaccine distribution.

“The adverse effects of the vaccine—even if, at worst, they all happen at once—are transient and a normal sign of reactogenicity signaling an effective immune response,” Choi writes.

To which some patients might respond: “Do tell more.”

Choi writes in her JAMA Network article: “My arm quickly became painful at the injection site, much more than the first time. By the end of the day, I felt light-headed, chilled, nauseous, and had a splitting headache. I went to bed early and fell asleep immediately. Around midnight, I woke up feeling worse—feverish and chilled, nauseated, dizzy, and hardly able to lift my arm from muscle pain at the injection site.”

But, as Choi says, these are temporary effects and not everybody will have such a severe reaction. Getting immunity from COVID-19 will be well worth any temporary discomfort that a vaccine might cause. Choi adds, however, that many might not see it that way. She writes that “I worry that they could be a major barrier to vaccine uptake. Clinicians will need to be prepared to discuss with patients why they should trust the vaccine and that its adverse effects could look a lot like COVID-19. They will need to explain that fatigue, headache, chills, muscle pain, and fever are normal, reactogenic immune responses and a sign that the vaccine is working, despite the unfortunate similarities with the disease’s symptoms.”