This morning, an ICU nurse at Long Island Jewish Medical Center in Queens became the first person in the United States to receive the first and only FDA-approved COVID-19 vaccine. Over the weekend, the FDA and CDC approved Pfizer and BioNTech’s BNT162b2, an mRNA-based vaccine to fight COVID-19. The timing is apt as the U.S. hit record-high COVID-19 hospitalizations on Friday.
Officials with Operation Warp Speed, the task force in charge of vaccine delivery, have told media outlets nearly 3 million doses of Pfizer’s vaccine have been sent out in the initial shipment, followed by an additional 3 million 21 days later for patients to receive their second shot. Pfizer’s vaccine requires the two doses three weeks apart. Still, states expect to exhaust their vaccine supply within days of today’s shipment.
In July, the U.S. government signed an agreement with Pfizer to deliver 100 million doses of BNT162 immediately after approval, with the option to acquire 500 million additional doses throughout 2021. This morning, Pfizer CEO Albert Bourla said the pharmaceutical manufacturer is working with the U.S. government to find a solution to deliver 100 more doses in the second quarter of 2021, rather than the third quarter.
On Friday. Dec. 17, the FDA is scheduled to have a meeting regarding the potential approval of Moderna’s mRNA-1273 COVID-19 vaccine. If that meeting follows the Pfizer template from last week, the U.S. could have a second coronavirus vaccine approved by the weekend. Between Pfizer’s and Moderna’s shots, Warp Speed officials have estimated 20 million Americans could begin the vaccination process by the end of this month. Moncef Slaoui, the chief advisor for Warp Speed, has projected 30 million more Americans will be immunized in January 2021, and 50 million more in February 2021.
However, an approved vaccine is only half the battle—now, citizens need to be willing to get vaccinated. According to survey results released earlier this month by Pew Research Center, 60% of Americans said they would definitely or probably get a vaccine for the coronavirus. While that is considered low for adults, it is an increase of 9% over the prior survey published in September 2020. Further illustrating that confidence is growing, 75% of those surveyed in December said they have at least a fair amount of confidence in the R&D process now, compared with 65% who answered that way in September.
The national survey was conducted Nov. 18 to 29, 2020 among 12,648 U.S. adults. At that time, there was no vaccine approved by the FDA, but both Pfizer and Moderna’s Phase 3 trial data showed 90%+ efficacy with both moving toward emergency use authorization. At the time, 39% of survey respondents said they definitely or probably would not get a coronavirus vaccine; however, half of the group—18%—said it’s possible they would decide to get vaccinated once others did so and more information became available.
With the rapidness of COVID-19 R&D, trials and approvals, long-term safety is a point of contention for some. Normally, after the FDA clears a vaccine for use, it requires researchers to track side effects for at least 6 months among those vaccinated in clinical studies. However, due to the urgency of the COVID-19 pandemic, the FDA requires only two months of safety follow-up for about half of those vaccinated during clinical trials.
Since Pfizer’s vaccine approval in the UK, there have been multiple reports of allergic reactions, and 4 people on the FDA assessment team voted no to approving BNT162b2 due to their concern about the effects it could have on 16-year-olds, the youngest approved age group.
In response, the CDC has launched V-safe, a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after one receives a COVID-19 vaccination.
“Through v-safe, you can quickly tell CDC if you have any side effects after getting the COVID-19 vaccine. Depending on your answers, someone from CDC may call to check on you and get more information,” the CDC website explains.
The V-safe system will also remind patients when it is time to receive the second vaccine.
While the CDC already had an existing vaccine safety monitoring infrastructure—including an event reporting system, electronic health records, a vaccine safety datalink and more—V-safe is part of the agency’s expanded safety monitoring system, given the unprecedented pandemic and need for real-time solutions. In addition to V-safe, the CDC created the National Healthcare Safety Network, an acute care and long-term care facility monitoring system with reporting to the Vaccine Adverse Event Reporting System. The FDA has also collaborated with large insurer/payer databases to develop a similar system of administrative and claims-based data for surveillance and research.