CDC’s Immunization Panel Discusses COVID-19 Vaccines as EUA Decision Looms

As the countdown begins toward an eagerly anticipated FDA authorization for Pfizer’s COVID-19 vaccine candidate, an advisory committee of the Centers for Disease Control and Prevention (CDC) is meeting today to discuss the phased distribution of coronavirus vaccines.

And the FDA has scheduled a Dec. 10 meeting of its vaccines advisory committee to discuss the Emergency Use Authorization (EUA) request filed on Friday by Pfizer and BioNTech.

FDA Commissioner Stephen Hahn did not say how long the agency will take to review the EUA request but said Americans could see a vaccine rolled out to high-priority patients in a matter of weeks.

Former FDA chief Scott Gottlieb called the filing “good news” and estimated it would take the agency two to four weeks to review, meaning a decision is likely to be made midway through December.

“We could start vaccinating a select group of vulnerable Americans, probably elderly Americans, people who live in … nursing homes, as early as mid-December, so it could have some impact on the current epidemic that we’re going through,” he said.

HHS Secretary Alex Azar projected last Wednesday that both Moderna’s and Pfizer’s vaccines could obtain emergency clearance in less than a month, and Moderna is expected to file soon for an EUA (DID, Nov. 20).

Pfizer Chairman and CEO Albert Bourla called the landmark EUA filing “a critical milestone” for the vaccine. “We now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” he said.

Both vaccines, which are based on unproven messenger RNA technology, have shown strong efficacy. Pfizer/BioNTech’s candidate, BNT162b2, demonstrated 95 percent efficacy, according to its final late-stage analysis, while Moderna’s first interim analysis found its vaccine, mRNA-1273, was 94.5 percent effective. Moderna is expected to file for an EUA shortly after it completes its final efficacy analysis.

While logistical concerns persist over the Pfizer vaccine’s need to be shipped at ultra-cold temperatures, BioNTech said that it is working to develop a formula that will allow shipping at room temperature (DID, Nov. 19). Pfizer currently estimates that there will be up to 50 million doses ready for global distribution this year and 1.3 billion doses by the end of 2021 and has said that it will ship out the vaccine “within hours after authorization.”

The government will deliver the Moderna vaccines and the initial doses of Pfizer’s vaccines through its partnership with distribution titan McKesson and has said that it will cover the costs for vaccinations. Pfizer has worked with the government on its own strategy for distribution that it will use after those initial dose deliveries, and to that end, it has launched a pilot program in four U.S. states that is testing out its plan in different regions (DID, Nov. 18).

Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, last week lauded the high effectiveness rates of both Pfizer’s and Moderna’s vaccines. “For those of you not acquainted with the field of vaccinology, that is extraordinary,” he said. “That is almost to the level of what we see with [the] measles [vaccine], which is 98 percent effective.”

Meanwhile, according to reports from Europe, the EU is in negotiations to pay more than $10 billion for hundreds of millions of shots of vaccines from Pfizer and CureVac. CureVac is farther behind in its vaccine trials than Pfizer, Moderna and other competitors, but expects to begin late-stage trials by the end of the year. — James Miessler