An advisory panel to the US Food and Drug Administration has recommended the emergency approval of a Covid-19 vaccine developed by Pfizer and BioNTech.
The recommendation is expected to signal that the first approval of a Covid-19 vaccine for use in the US is imminent. That would mark a major milestone in a pandemic that has killed more than 285,000 Americans and 1.5 million people globally.
If the FDA grants emergency approval, the US would be the third country in the world to have authorized the use of the Pfizer/BioNTech vaccine in the broader public behind the UK and Canada, and it will be the most populous country to do so.
In more data on the vaccine released in the New England Journal of Medicine on Thursday, Pfizer and BioNTech said the vaccine was 95% effective in a randomized controlled trial of more than 43,000 people. An accompanying editorial in the journal described the vaccine’s development as a “triumph” for science.
“Most vaccines have taken decades to develop, but this one is likely to move from conception to large-scale implementation within a year,” wrote Dr Eric J Rubin, the editor-in-chief of the journal, who co-authored the editorial.
The vaccine uses messenger RNA technology to introduce the body to the spike protein found on the outside of the coronavirus to provoke an immune response. It requires two doses, administered three weeks apart.
Scientists are still studying how long the vaccine will protect people, the safety and efficacy of the vaccine in children and pregnant women, and the rate of asymptomatic disease in vaccine recipients.
In a statement following the vote, Joe Biden called the move “a bright light in a needlessly dark time”.
Hoever, the president-elect also noted that “vaccines don’t equal vaccinations”.
“Our challenge now is to scale up manufacturing and distribution to distribute 100 million shots in the first 100 days of my administration,” he said. “Before I take office, we need the Trump Administration to purchase the doses it has negotiated with Pfizer and Moderna and to work swiftly to scale manufacturing for the US population and the world. And, we will need Congress to fund our distribution efforts.”
The vote was not without late dissent. Four of the 22-voting member panel voted against issuing an emergency authorization, after late debate about whether to remove 16- and 17-year-olds from the authorization.
Some experts argued the data on this subgroup was “thin” and that the panel should recommend further study. But others said the safety and efficacy data to date was enough for emergency use, not least because this group is unlikely to get the vaccine for months because of supply constraints.
“We have clear evidence of benefit and all we have on the other side is theoretical risk,” said Dr Paul Offit, a vaccine expert at Philadelphia Children’s Hospital.
Another major concern for the panel was how to continue blinded placebo-controlled trials if the FDA issues an emergency authorization, as it is expected to. That is because once an emergency authorization is issued, it would be unethical to keep trial participants from finding out whether they received a placebo, and ultimately getting the vaccine.
The FDA could approve the vaccine for emergency use at any time after the advisory committee meeting, and the Trump administration is pushing for speedy approval. But the FDA must signal it is giving safety and efficacy concerns due consideration. Vaccines in general have a higher bar for approval than many medicines, because they are given to healthy adults.
Approving a vaccine too quickly could stoke public skepticism, and lead to higher levels of vaccine hesitancy. Too slow an approval puts more lives at risk. More than 2,000 Americans per day and 80 Americans per hour are killed by the virus. The FDA takes the actions recommended by its advisory panels about 78% of the time, according to a recent study by the Milbank Quarterly.
The panel’s recommendation comes as the pandemic is pushing the American health system to the brink. More than 192,000 Americans per day are being diagnosed with Covid-19, hospitals across multiple states are filled to capacity and healthcare workers are exhausted. This week, for the first time in the pandemic, more than 3,000 people died of Covid-19 in one day.
But even this horrific toll is considered a severe undercount by the US Centers for Disease Control and Prevention (CDC), which said at the advisory committee meeting Thursday that reported infections, hospitalizations and deaths are likely two to seven times below the virus’s actual toll.
“The under-reporting of deaths, for example, has changed over time,” said Dr Aron Hall, chief of the CDC’s respiratory viruses branch. But, he added: “The reported number of deaths is likely an underestimate of the true number of deaths.”
The CDC estimates that Covid-19 has caused 2.4 million hospitalizations, 44.8 illnesses and 52.9 million infections. Infection rates are expected to increase as people infected during the Thanksgiving holiday fall ill, and people gather for Christmas in spite of health experts’ warnings not to do so.
But even as any vaccine approval would be a landmark achievement, set a record for vaccine development and bring new technology to the public, it will not be a silver bullet to end the pandemic.
Extremely limited supplies of the Pfizer vaccine mean only about 20 million people will be vaccinated at first. A CDC advisory committee has recommended states allocate those limited supplies to health workers and the elderly living in long-term care facilities, together roughly 23 million people.
That means Americans will need to continue to social distance, wear masks, hand-wash and avoid crowds – even as the vaccine brings containment of the virus within striking distance.
Further, Pfizer’s vaccine presents extreme logistical challenges, because it must be stored at -94F (-70C), transported on dry ice in specialized containers, staff must be trained in how to handle these containers, and the vaccine can be shipped in quantities no smaller than 975 doses.
With this in mind, experts are hoping a second vaccine – only a week behind in the approval process – will also be recommended for approval soon. The second vaccine is developed by the National Institute of Allergy and Infectious Diseases and Moderna. A hearing for that vaccine candidate is scheduled for 17 December.