Azar Says EUA May Soon Be Granted for Pfizer and Moderna’s Vaccines

Both Moderna’s and Pfizer’s COVID-19 vaccine candidates could receive Emergency Use Authorization (EUA) in less than a month and be ready for rollout in a matter of weeks, HHS Secretary Alex Azar said Wednesday, giving hope that high-risk patients could receive a vaccine before the year ends.

Speaking during a briefing on Operation Warp Speed, Azar said that should an EUA be granted, the government will deliver the shots to vulnerable, prioritized Americans using major distributor McKesson, which it has partnered with, and a “direct arrangement” with Pfizer, and administration costs will be covered by the government and private insurers, he said.

Azar said the government expects to have 40 million doses of the two vaccines available for distribution by the end of the year, enough to vaccinate about 20 million Americans, with production continuing to accelerate in the new year.

The FDA is expected to assemble its vaccines advisory committee Dec. 8-10 to discuss the recent developments, including Pfizer/BioNTech’s and Moderna’s candidates. The agency said it was unable to comment on the potential meetings.

Pfizer announced yesterday that its COVID-19 vaccine candidate shows a stunning 95 percent effectiveness and that the company will file within days — perhaps before the week ends — for an EUA.

Joint developers Pfizer and BioNTech released the highly promising efficacy results from their phase 3 trial’s final efficacy analysis, based on 170 confirmed coronavirus cases. While 162 cases were from the placebo group, just eight were from the group given the BNT162b2 vaccine.

Further, the analysis found adults over 65 — a population that is more vulnerable to COVID-19 and likely to be prioritized during initial rollout — saw almost the same efficacy rate at more than 94 percent.

BioNTech is now working on developing a vaccine formula that will allow it to be shipped at room temperature, according to CEO Uğur Şahin. Currently, the vaccine faces a serious distribution challenge as it must be shipped at the ultra-cold temperature of -94 Fahrenheit (F) that could be difficult and expensive to accommodate.

The Pfizer/BioNTech trial will continue to collect efficacy and safety data from participants for two years, but the vaccine appears safe so far, raising no serious safety concerns. The only notable adverse events were fatigue and headache in a small percentage of participants, 3.8 and 2 percent respectively, the companies said.

Former FDA Commissioner Scott Gottlieb hailed Pfizer/BioNTech’s success as a “game change” and predicted their vaccine could be the solution to the health crisis.

“This is a great day for patients,” the former agency chief said. “We should now have two vaccines that could effectively end the U.S. epidemic next year if everything goes right.” The second vaccine Gottlieb referenced is presumably Moderna’s vaccine candidate, mRNA-1273.

Ashish Jha, dean of the Brown University School of Public Health, said during a televised interview that the Pfizer/BioNTech vaccine’s high effectiveness is “fabulous” and “will make an enormous difference in the pandemic,” but he cautioned that the full set of data still needs to be appraised.

“Pfizer’s really done an amazing job on this. They have been thinking about these things for months and planning ahead, and that’s gonna make a big difference,” Jha said. “The vaccine needs to be stored at -94F. That’s a huge challenge, but I’m actually pretty confident we’ll be able to overcome that issue.”

Moderna, whose vaccine candidate doesn’t need such extreme temperatures to be distributed, will likely finish its final efficacy analysis and announce the vaccine’s conclusive efficacy rate soon, followed by an EUA request. Its first interim analysis found its vaccine was 94.5 percent (DID, Nov. 17).

In contrast to the flurry of good news for vaccines recently, China’s Sinovac announced Tuesday it has seen mixed results in the phase 1/2 trial of its vaccine candidate. While the vaccine generated immune responses in participants, it led to lower levels of antibodies than were seen in patients that recovered from COVID-19, the researchers said in The Lancet. — James Miessler