After more than nine months of a pandemic that has sickened and killed millions worldwide, the United States is on the verge of obtaining its first federally reviewed COVID-19 vaccine.
The Vaccines and Related Biological Products Advisory Committee, a group of independent scientists and researchers from institutions all over the country, will hold a public meeting today to discuss Pfizer and BioNTech’s vaccine.
Committee recommendations will determine the U.S. Food and Drug Administration’s decision to issue an emergency use authorization, or EUA, for the vaccine, potentially getting doses in the hands of Connecticut health providers within the week.
“The CDC has told us that they will ship the vaccine within 24 hours of emergency use authorization,” said Eric Arlia, director of systems pharmacy at Hartford HealthCare. “So we have teams ready. Even if it comes over the weekend, we’ll be prepared to receive it.”
EUAs make it possible for health care professionals and others to use medical products and interventions, including vaccines, that have not yet gotten FDA approval in order to address a public health emergency or significant disease outbreak.
Normally, it can and often does take years for a new vaccine to get approval, also known as licensure.
Dr. Saad Omer, director of the Yale Institute for Global Health, said vaccines going through the EUA process still require rigorous testing and review.
“It is happening after Phase 3 trials. So, it’s not a shortcut in terms of number of trials or the kinds of trials being done,” he said. “There are large trials that have looked at safety and efficacy, so that’s the circumstance in which it is happening.”
Omer said these vaccine requests for EUAs must also show a significant amount of data and scientific evidence pointing to their safety and effectiveness.
“And FDA has gone out of their way to make sure that those data are actually shared publicly, so that independent scientists can go and see what is going on and provide confidence in the process,” he said.
The drug manufacturers have tested the vaccine in more than 40,000 people at clinical trial sites across the globe, including at Yale Medicine and Yale New Haven Health.
A report by FDA staff earlier this week concluded that the vaccine is highly effective -- around 95% -- in preventing COVID-19 and that there are no “specific safety concerns” that would prevent the Pfizer-BioNTech vaccine from getting authorized.
The report noted that some trial participants experienced side effects, although the majority of them were mild and temporary in nature. They included pain at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever.
“The reason that you’re having that muscle ache, a little bit fatigue, maybe a little bit of chills, has everything to do with the fact that that’s your immune system waking up and recognizing this spike protein and generating the immune response,” said Dr. Patrick Troy, division chief of pulmonary critical care and sleep medicine at Hartford Hospital.
The frequency of a serious side effect occurred less than 0.5% of the time.
Omer said the federal committee will have to determine if the benefits of an unapproved, but largely tested COVID-19 vaccine substantially outweigh the risks of letting the pandemic rage on without one.
As of Tuesday night, there have been 140,548 confirmed and probable COVID-19 cases in Connecticut since the start of the pandemic. Nearly 5,300 people in the state have died.
“[The pandemic] is causing not just disease, but death of unparalleled magnitude,” Omer said. “People are at risk of death and disease, either themselves or them transmitting to others who have a higher risk. So based on this, all of this will have to be taken into account when authorization is granted for these early vaccines.”
Health providers and experts predict that the FDA, with the federal committee’s vote, will issue an EUA by the end of the week or soon after.
After distribution to the public, Omer said, the pharmaceutical manufacturers and the government will continue to conduct long-term monitoring and surveillance. This will be needed for vaccines to eventually achieve FDA approval.
Pfizer vaccines in Connecticut will initially go to health care workers and people in long-term care facilities.
A federal committee meeting for a COVID-19 vaccine made by biotech company Moderna is set for Dec. 17.