Pfizer (PFE) and BioNTech’s (BNTX) vaccine is one step closer to being distributed to health workers and nursing home residents, with the U.S. Food and Drug Administration’s (FDA) vaccine advisory committee recommending its emergency use authorization (EUA) on Thursday.
The 17-4 vote, with one abstention, could result in the FDA authorizing the vaccine within a matter of days, which would then trigger the distribution of the vaccine throughout the 64 jurisdictions in the U.S., including 50 states, Tribal Nations and several territories.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said Wednesday that the agency would take “days to a week” to issue an EUA.
FDA Commissioner Stephen Hahn reinforced the message, dimming hopes of an authorization on Friday. Hahn said late Thursday that, “FDA staff feel the responsibility to move as quickly as possible. However, they know they must carry out their mandate to protect the public health & ensure any authorized vaccine meets our rigorous safety and effectiveness standards that the American people have come to expect.”
President-elect Joe Biden’s team initially incorrectly congratulated the FDA on granting emergency use, but later released a statement saying the milestone marked “a bright light in a needlessly dark time,” and that more work lay ahead to continue to ramp up production to begin the mass vaccinations next year.
Meanwhile, Dr. Robert Redfield, director of the U.S. Center for Disease Control and Prevention (CDC) said COVID-19 has become the leading cause of death in the U.S., surpassing heart disease, which previously held the designation.
A CDC official told the FDA advisory meeting that its studies have shown that prevalence of the virus is two to seven times higher than the reported positive cases, which came in at more than 14.8 million as of Thursday.
It’s why health systems around the country have already begun to schedule shots for their frontline workers, some scheduled for as early as December 15, with the intention to adjust timing for when the vaccine becomes available.
Even though Pfizer has done “stress tests” of its logistics chain, no doses have been sent to any states or health systems, according to Operation Warp Speed Chief of Operations, Gen. Gustave Perna.
Perna told NBC Nightly News on Wednesday that, “All the vaccine is currently with Pfizer ... and we will not move it forward until we have an EUA.”
Margaret Keenan, 90, is applauded by staff as she returns to her ward after becoming the first patient in the UK to receive the Pfizer-BioNTech COVID-19 vaccine, at University Hospital, Coventry, England, Tuesday Dec. 8, 2020. The United Kingdom, one of the countries hardest hit by the coronavirus, is beginning its vaccination campaign, a key step toward eventually ending the pandemic. (Jacob King/Pool via AP)
If authorized, as it is anticipated to be, Pfizer’s and BioNTech’s vaccine will have gained approval in four countries.
The U.K. authorized the vaccine last week and administered the first doses Tuesday. Bahrain next authorized the vaccine, though little is known about the country’s agreement for doses. It previously authorized a Chinese vaccine, which it has administered to about 6,000 people.
The U.K.’s authorization was based on intermittent data submissions from the companies’ clinical trials, which is how it became the first country to authorize the vaccine. The FDA, on the other hand, operates on a final packaged submission, and requires independent review of the data by the agency.
According to the Marks, this helps ensure the strongest level of confidence in the product.
“We're one of the only regulatory bodies in the world” that doesn’t just take the data companies give them, he said at the White House vaccine summit Wednesday. “Sometimes we learn things the manufacturers didn't even know by doing our analyses.”
The authorization is widely expected by the end of the week. Pfizer officials said during the meeting Thursday that they expect to accumulate enough safety monitoring data to apply for full licensure in April 2021.
It’s unclear why four voted against recommending, but one member said it was related to the discussion prior to the vote, which centered on the framing of the question. The committee voted on recommending authorization to vaccinate people 16 years or older, rather than 18 and older. Some said there wasn’t enough data to support the move since the trial only included 18 and older, while others pointed to less need in the younger and healthier population.
Dr. Arthur Caplan, a top vaccine expert, bioethicist, and professor at NYU Langone, told Yahoo Finance the age distinction doesn’t matter. “They are so far back at the end of the line that it doesn’t matter,” he said.
More questions than answers
Questions at the advisory meeting Thursday focused on key issues that health officials have had for some time, though most went without definitive answers.
Many experts want to know whether or not the vaccine can prevent transmission. Pfizer officials said they will be studying that, and the CDC will be monitoring vaccine recipients, according to FDA officials Thursday.
Oxford has already seen a promising trend in its vaccine trials with AstraZeneca (AZN), according to Adrian Hill, who leads the institute overseeing the trial. Hill told NBC Nightly News, “We see that the vaccine is having an impact in reducing transmission.”
The possibility of Pfizer’s vaccine being a one-dose vaccine was another key point of interest. The concern comes from strong results in the Phase 3 trial showing more than 90% efficacy a week after the vaccine had been administered. Since the trial only studied the vaccine as a two-dose shot, it must remain so, with a booster given after 21 days.
But Pfizer officials said they were interested in looking at the option of a one-does vaccine. If it succeeded, it would be the second, along with Johnson & Johnson (JNJ), to have a single-dose vaccine.
Allergy concerns
Following two reports of allergic reactions in the U.K., vaccine expert Dr. Paul Offit asked about plans to address the implications for the tens of millions of individuals with allergies in the U.S.
FDA officials said the information would be included in information sheets that are sent along with the vaccine for health providers and patients. A Pfizer official said that participants were not included in the trials if they had prior allergic reactions to vaccines, but it remains unclear how many clinical trial participants had food allergies.
The same Pfizer official also noted that the U.K. reported one patient had prior allergic reactions to an undisclosed drug and one had food allergies.
Offit suggested the company conduct a study on people with allergies.
Another pressing issue concerns what happens to trial participants in the placebo group, since members could leave the trial if they eventually become eligible to receive a vaccine in the real world. The FDA is hoping to have these individuals stay unvaccinated in order to complete the trial with full integrity.
Caplan said this is what worries him the most.
“Clinical trials are in trouble,” he said, noting that if participants leave the trial and are vaccinated, precious data will be lost.
Even with the government’s plan to follow all vaccine recipients for safety monitoring through several platforms and databases, it is unlikely to be a strong effort, he said. “Drug companies and biotechs have never done a good job of following people,” and the government’s system has never faced such a strenuous test, he added.
“Everything going forward is based on the ability to follow who got vaccinated and who got the second doses,” Caplan said.
The meeting also addressed implications for future vaccine candidates. Once the vaccine receives an EUA, it’s likely that future vaccines could be precluded from receiving a similar authorization — instead having to apply for full licensure — unless the supply of vaccines is still too low.
Meanwhile, Pfizer and BioNTech are gearing up for the next step.
Pfizer CEO Albert Bourla said in a statement late Thursday, “if the FDA issues an authorization, (we) stand at the ready to bring this vaccine to people in the U.S. in an effort to help combat this devastating pandemic.”
