FDA committee recommends authorizing use of second COVID-19 vaccine in US
An FDA advisory committee voted Thursday to recommend that a second COVID-19 vaccine be authorized for emergency use in the United States.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 20-0 with one abstention in favor of authorizing the vaccine’s use in adults aged 18 years or older, setting the stage for the FDA to issue a second emergency use authorization (EUA) for a vaccine in as many weeks, which it is widely expected to do.
The messenger RNA (mRNA)-based vaccine developed by Moderna Inc. and the NIH was shown to be safe and highly efficacious in an ongoing phase 3 trial, according to results released by Moderna last month that were confirmed in an FDA document published this week.
Last week, the VRBPAC endorsed another mRNA-based vaccine developed by Pfizer and BioNTech, which was followed a day later by the FDA issuing an EUA for the vaccine for patients aged 16 years or older. Priority groups, including health care workers, began receiving that vaccine on Monday amid a record surge in cases in the U.S.
According to tracking by Johns Hopkins University, more than 17 million people in the U.S. have been diagnosed with COVID-19 since the start of the pandemic, and nearly 309,000 people have died.
The availability of two highly effective vaccines “is going to finally turn the tide on this pandemic, and quickly,” said Monica Gandhi MD, MPH, professor of medicine and associate chief of the division of HIV, infectious diseases and global medicine at the University of California, San Francisco.
“The efficacy of the vaccines is higher than we could have imagined a year ago and — with two options — distribution and administration should occur quickly,” Gandhi told Healio. “If 70% population level immunity is needed to still viral spread, I think this is achievable in the United States by the summer of 2021.”
In a VRBPAC briefing document published online this week, the FDA confirmed that the Moderna vaccine was 94.1% efficacious in preventing symptomatic COVID-19, based on 196 cases among the study population as of Nov. 21 — 185 in the placebo group and 11 in the vaccine arm. All 30 documented cases of severe COVID-19 among the study population occurred in the placebo arm.
“It’s wonderful that this vaccine has such great efficacy and a great safety profile,” Krutika Kuppalli, MD, assistant professor of medicine in the division of infectious diseases at the Medical University of South Carolina, told Healio. “Hopefully we will be able to get more people to have confidence in the vaccine and take it up.”
Gandhi noted that Moderna’s phase 3 trial enrolled over a third of participants from communities of color and over 25% were over age 65 years, in whom the vaccine was 86.4% efficacious.
In contrast to the Pfizer and BioNTech vaccine, which needs to be stored at nearly –100°F, the Moderna vaccine is stable for 30 days in a regular medical or home refrigerator, which will make it more accessible, Kuppalli said.
“It doesn't need that ultra-cold storage, so we'll be able to make the rollout of the vaccine a bit more feasible for people who live in more rural areas of the United States and other parts of the world where this vaccine will be rolled out,” she said.
In response to claims that it was having production issues, Pfizer said Thursday that it had successfully shipped all 2.9 million doses of vaccine requested by the U.S. government to the locations where it was asked to ship them.
“We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses,” the company said in a statement.
Pfizer said it will ship up to 50 million doses of the vaccine globally by the end of this year and up to 1.3 billion doses in 2021. Some locations in the U.S. discovered this week that vials of vaccine delivered by Pfizer contain more doses than expected. The FDA said it OK to use every full obtainable dose from each vial, but that less-than-full doses should not be pooled together from different vials.
Moderna has said that it will have approximately 20 million doses of its vaccine ready to ship in the U.S. by the end of 2020 and up to 1 billion doses available globally in 2021. Both vaccines are given in two doses — Pfizer’s 21 days apart, and Moderna’s 28 days apart.
“This is really a great moment for science in terms of what we have been able to do so quickly in the setting of this horrible pandemic,” said Kuppalli.
Like many health care workers, Kuppalli received the first dose of the Pfizer vaccine earlier this week. Residents of long-term care facilities are also being prioritized in the first wave of vaccinations.
“I had very mixed feelings in terms of being excited to be in the first round of vaccinations but [also] definitely feeling a little bit sad and feeling a little bit guilty because there are so many people out there who need this life saving therapeutic,” Kuppalli said. “I really want to make sure that we are able to get it to everyone who needs it. I’m very happy that we're moving forward with this process to try and continue to scale up our vaccine production and vaccine rollout for everybody who needs it and not just here, but really, we need to do this all over the world.”
FDA Vaccines and Related Biological Products Advisory Committee Meeting. FDA briefing document: Moderna COVID-19 vaccine. https://www.fda.gov/media/144434/download. Accessed December 17, 2020.