The U.S. Food and Drug Administration (FDA) released on Tuesday its first analysis of data from the Pfizer/BioNTech coronavirus vaccine clinical trials. The agency’s scientists found that the two-dose vaccine candidate was highly effective in participants, regardless of age, race or other risks for severe illness from COVID-19. No safety concerns were identified, but some participants did experience mild to moderate side effects such as injection site pain, fever, fatigue, headache, muscle pain and joint pain, the FDA analysis shows. Next step: The FDA and its outside panel of experts will discuss the data and potential emergency use authorization (EUA) for the vaccine on Dec. 10.
The first coronavirus vaccines may be available as early as mid-December, according to federal officials, following the Dec. 10 and Dec. 17 advisory meetings to review data from the Pfizer and Moderna vaccine trials. If the FDA authorizes a vaccine, distribution will start almost immediately for priority populations — health care workers and staff and residents of long-term care facilities — and the hope is that “administration could begin as soon as the product arrives,” U.S. Health and Human Services (HHS) Secretary Alex Azar said in a news briefing. The U.S. government expects to have 40 million doses of coronavirus vaccine by the end of the year, which is enough to vaccinate 20 million people (a full dose requires two shots).
Britain has started vaccinating its priority populations after granting emergency authorization to Pfizer/BioNTech’s coronavirus vaccine and becoming the first Western country to greenlight vaccination against COVID-19. HHS Secretary Azar said in a recent press briefing that “the approval of another independent regulatory body should give Americans additional confidence in the quality of such a vaccine.”
A federal advisory group of medical and public health experts, known as the Advisory Committee on Immunization Practices (ACIP), said on Dec. 1 that the first coronavirus vaccines should go to health care workers and residents and staff of long-term care facilities once a vaccine is authorized by the FDA and recommended by the ACIP. The U.S. has invested in advanced manufacturing, but even still, initial vaccine supplies will be limited which is why the committee meets to determine prioritization. The recommendations were approved by Centers for Disease Control and Prevention (CDC) Director Robert Redfield.
Nearly 60 percent of Americans ages 50 to 80 said they are somewhat or very likely to get a coronavirus vaccine when one becomes available, according to a new survey from University of Michigan’s National Poll on Healthy Aging. That number shot up even higher when researchers asked the question a different way, although it exposed some hesitancy: One in five older adults indicated they want to get a vaccine to protect against COVID-19 as soon as possible; nearly half (46 percent) said they want to wait to get a vaccine until others have received it. The greatest interest in getting a vaccine was among those 65 to 80, the poll found. Older adults are at increased risk for hospitalization and death from COVID-19.
Another vaccine candidate is showing promising results in its phase 3 clinical trials. Pharmaceutical company AstraZeneca with Oxford University announced on Nov. 23 that its coronavirus vaccine was found to be about 70 percent effective, on average, at preventing COVID-19 when administered at two different dosing regimens in an interim analysis in its clinical trials in the U.K. and Brazil. The company is also testing the vaccine in clinical trials in the U.S., Japan, Russia, South Africa, Kenya and Latin America; the information from these trials is not yet available. Both the Pfizer/BioNTech and Moderna vaccines have reported efficacy rates of more than 90 percent.