With the FDA perhaps days away from granting emergency use authorization (EUA) for the first U.S. COVID-19 vaccine, the Trump administration took a bow Dec. 8 at a summit called to celebrate what’s been accomplished and to explain what lies ahead in getting vaccines distributed throughout the country.
President Donald Trump called the development of a “gold-standard” vaccine in less than nine months “one of the greatest miracles in the history of modern-day medicine” – a miracle that he said would end the pandemic.
The next step is to get the vaccine to the people who need it. If the FDA authorizes the Pfizer Inc./Biontech SE COVID-19 vaccine as expected, followed by a vaccine from Moderna Inc., President Donald Trump said tens of millions of doses would be available this month, with hundreds of millions of doses within just a few months. Although he doesn’t anticipate it will be needed, Trump said he’s prepared to invoke the Defense Production Act to ensure the vaccines are readily available.
As part of its $14 billion investment in the development and manufacture of COVID-19 vaccines, the U.S. government has reserved hundreds of millions of vaccine doses and optioned even more from the companies making them. That assures the government a supply that far exceeds what will be needed to vaccinate the entire U.S. population of about 330 million people.
Although Trump signed an executive order Tuesday to ensure Americans have first priority for the vaccines the government has reserved, he said the U.S. is working with other countries to get the vaccine out to them. With millions of doses being manufactured, he said the U.S. should be able to start sharing its supply with other countries “almost immediately.”
The U.S. is already sharing its COVID-19 research and ventilators with other countries, Trump said, adding that “life will be much easier for [millions of people] because of what we’ve done.”
The summit came two days ahead of an FDA advisory committee meeting on the Pfizer/Biontech vaccine BNT-162b2. Although it seems to be a foregone conclusion that the FDA will be granting an EUA to the vaccine within a few days, that doesn’t mean the Dec. 10 adcom meeting will be just a “check-the-box” event.
The experts on the Vaccines and Related Products Advisory Committee will be asked to discuss whether it’s reasonable to believe, based on the evidence, that the vaccine is effective in preventing COVID-19 infections in individuals age 16 or older and that the benefits of the vaccine outweigh its risks.
They also will be asked to advise on additional studies the sponsors should conduct “following issuance of the EUA to gather further data on the safety and effectiveness of this vaccine,” the FDA said in its briefing document for the meeting.
But in addition to that discussion, the FDA has lined up experts to provide panelists with updates on the epidemiology of the coronavirus, vaccine monitoring, U.S. distribution plans and considerations for other placebo-controlled vaccine trial designs once an unlicensed vaccine is available through an EUA.
As far as it’s concerned, the FDA said Pfizer’s data from about 38,000 trial participants “suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA.”
In terms of effectiveness, the agency confirmed similar efficacy point estimates of about 95% “across age groups, genders, racial and ethnic groups, and participants with medical co-morbidities associated with high risk of severe COVID-19.” At the summit, Trump noted that the 95% efficacy far exceeded expectations. FDA guidance calls for COVID-19 vaccines to demonstrate at least 50% efficacy.
Secondary efficacy analyses suggested the vaccine may prevent severe COVID-19 and may prevent COVID-19 in individuals with prior SARS-CoV-2 infections. And it may take only one dose, even though the vaccine was tested as a two-dose regimen. However, the FDA cautioned that the available data for the secondary outcomes doesn’t allow for firm conclusions.
While the FDA’s briefing doc presented a rosy picture for the vaccine, it did disclose some new safety issues that, while not considered serious, are notable, Evercore ISI analyst Umer Raffat said. For instance, four individuals in the vaccine arm vs. none in the placebo arm developed Bell’s palsy and 64 on vaccine vs. six on placebo reported lymphadenopathy.
A few imbalances also were noted for serious adverse events (AEs). Eight individuals on the vaccine vs. four on placebo had appendicitis. Additionally, the FDA noted numerically higher rates of acute myocardial infarction and cerebrovascular accident in the vaccine arm, Raffat pointed out.
Given the recent surge in COVID-19 cases in the U.S. and the specter of more stringent lockdowns, those safety issues likely won’t set off alarms. “We have no major concerns with the safety profile highlighted in the briefing docs, though [we] believe there is room for other competitors to differentiate on solicited AEs,” J.P. Morgan Securities LLC analyst Cory Kasimov said.
When it comes to the value the vaccines bring the companies making them, Kasimov is maintaining a neutral stance. “Given the possibility of many future COVID-19 vaccines (some at potentially much cheaper prices) and the uncertain duration of [the] pandemic, we are cautious on the substantial amount of value that the market is already ascribing to these programs,” he said.