The U.S. Food and Drug Administration fully approved the Pfizer-BioNTech COVID-19 vaccine for those aged 16 and over Aug. 23, a decision expected to boost slowing vaccination rates.
The vaccine will be marketed in the U.S. under the brand name Comirnaty and will continue to be available under emergency use authorization for those aged 12 through 15 years.
“While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” acting FDA commissioner Dr. Janet Woodcock said.
FDA approval was based on data collected from clinical trials featuring 44,000 participants in the U.S., the European Union, Turkey, South Africa, and South America. The agency said the data showed the Pfizer vaccine was 91% effective in preventing COVID disease.
“Today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed," said Pfizer chair and CEO Albert Bourla.
"I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity.
"Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans now that we have FDA approval."
Connecticut public officials and business leaders believe the FDA's long-anticipated approval will both help overcome vaccine hesitancy and lead to more employers mandating employee vaccinations.
President Joe Biden urged employers to mandate vaccinations following the FDA announcement, while Gov. Ned Lamont said he hopes businesses will consider employee vaccinations as a requirement for being in the workplace.
"This is an important moment for our fight against the coronavirus as schools are set to return and more companies are looking to see the safe return to work," Lamont said.
"It is my hope that this approval leads even more people to receive their safe and effective COVID-19 vaccine."
Coronavirus cases, hospitalizations, and deaths have increased in Connecticut and around the country over the past six weeks.
That surge in cases led a number of Connecticut companies to delay scheduled employee returns to the office, while many cities and towns reimposed indoor mask mandates for all people, regardless of vaccination status.
The FDA approved the Pfizer vaccine for emergency use for adults last December, followed by similar approvals for the Moderna and Johnson & Johnson vaccines.
The Pfizer vaccine was then granted emergency use approval by the FDA for those aged 12-17 in May.
The U.S. Equal Employment Opportunity Commission also issued guidance in December that employers could mandate vaccinations, updating that guidance in May.
Lamont announced Aug. 19 that all Connecticut state employees must be vaccinated against COVID-19 by Sept. 27.
That mandate includes private and public school teachers and nursing home workers.
CBIA president and CEO Chris DiPentima said that until recently, most Connecticut employers relied on incentives and employee education efforts to drive vaccinations.
"We're already hearing that internal conversations are stirring up inside employers about, 'OK, now should we really consider mandating the vaccine, since it's fully approved by the FDA?'" he told the Connecticut Mirror.
"When it was out there for emergency use authorization only, employers knew they could mandate the vaccine without being liable, but there was still hesitancy.
"They really wanted to use the encouragement approach first. But that has, I think, run its course.
"Employers have been thinking for the past couple weeks—'what more can I do to really increase vaccination rates so my workplace is safe, and we can continue to try to put this thing behind us?'"
Bloomfield-based Cigna Corp. announced Aug. 18 that employees must be vaccinated against COVID-19 from Sept. 7 to enter any of the company's U.S. work sites, or be tested weekly.
"It's clear we need to do more to stop the ongoing spread of COVID-19, and unlike many aspects of the pandemic, keeping our worksites as safe as possible is something we can control," said Cigna's chief clinical officer, Dr. Steve Miller.
"Reducing the risk of exposure to COVID-19 not only protects our workforce and ensures we can continue to meet the needs of our customers and clients, it also helps protect our children and community members who cannot receive the vaccine for health reasons."
CVS Health reacted to Monday's FDA announcement by mandating COVID-19 vaccinations for its nurses, pharmacists, and corporate employees.
“I think you’ll have a few this week and next week, and then it's just going to pick up momentum,” DiPentima said. "It's going to snowball. We're in another chapter of really addressing this health crisis."
Connecticut is one of the leading states for vaccinations, with over 2.3 million people, or 65% of the total population fully vaccinated.
Fifty-two percent of the U.S. population is fully vaccinated, with the Pfizer vaccine accounting for 54% of those vaccinations, followed by Moderna (39%), and Johnson & Johnson (8%).
A June 30 Kaiser Family Foundation survey showed that three in 10 unvaccinated adults say they would be more likely to get vaccinated if a vaccine was to receive full FDA approval.
The poll also found that two-thirds of employed adults report their employer encouraged workers to get vaccinated and half say their employer provided paid time off to get the vaccine or recover from side effects.
Connecticut Bioscience Growth Council executive director Paul Pescatello said full FDA approval for the Pfizer vaccine creates "a reset button" for driving vaccination rates in the workplace.
"The gold standard is to have everybody vaccinated and to be able to say 'we have that protection in our workspace and employees can feel free to work along side each other less in fear of COVID infection,'" he said.
Pfizer's Groton research lab, home to 4,000 scientists, played a critical role in the development of the vaccine, analyzing the results of over 40,000 clinical trials to determine safety and efficacy.
Pescatello said the FDA is currently reviewing Moderna's application for full approval, which could be "weeks away," while Johnson & Johnson is expected to submit its application later this year.