A day after the FDA granted emergency authorization for the use of the Pfizer Inc./Biontech SE COVID-19 vaccine, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave a thumb’s up for the vaccine, as did the Western States Scientific Safety Review Workgroup.
With all the necessary greenlights, distributors began shipping 2.9 million vaccine doses across the U.S. early Dec. 14. Fedex reportedly delivered its first vaccine shipment to a Massachusetts hospital before 6 a.m. and anticipated making vaccine deliveries to nearly 80 different facilities before the day’s end. UPS also is making vaccine deliveries, expediting them through Next Day Air to select hospitals, clinics and other medical facilities to inoculate health care workers who, together with residents of long-term care facilities, will be the first to get the vaccine.
“This is undoubtedly a historic feat not only for vaccine development but also expedient deployment,” said Mike McDermott, president of Pfizer Global Supply.
Like the FDA’s emergency use authorization (EUA), ACIP’s interim recommendation is for the use of the vaccine in individuals 16 and older. Using the evidence-to-recommendation framework, ACIP determined the level of certainty for the benefits of the vaccine was high for preventing symptomatic COVID-19 infections.
However, it noted that no data are available to assess the vaccine’s efficacy in preventing asymptomatic infections. ACIP also found low certainty in the evidence for the estimate of preventing COVID-19-associated hospitalization and very low certainty for the estimate of preventing death.
Recognizing that data on hospitalizations and deaths are currently limited, ACIP said, “A vaccine that effectively prevents symptomatic infection is expected to also prevent hospitalizations and deaths.”
As for potential risks from the vaccine, ACIP found moderate certainty for serious adverse events and high certainty for reactogenicity. The committee recommended that before a vaccine is administered, an EUA fact sheet should be given to the recipient and caregivers. In addition, providers should counsel vaccine recipients about expected systemic and local reactogenicity.
But overall, “for most populations, the desirable effects outweigh the undesirable effects,” ACIP said of the vaccine. And despite its “difficult ultracold-chain storage and requirements for handling and administration,” the vaccine should be feasible to implement, the committee added.
Recognizing that the storage and handling requirements could impact health equity by limiting the availability of the vaccine to some populations, ACIP advised that efforts should be made to overcome those challenges.
Although the U.S. government is covering the cost of the vaccine for all Americans, providers can charge for administering it. The ACIP recommendation triggers payer coverage of vaccine costs.
While FDA authorization and the ACIP recommendation were all that were necessary to start distribution and administration in most states, California, Nevada, Oregon and Washington had erected one other hurdle: an independent review by the newly created Western States Scientific Safety Review Workgroup, consisting of 10 medical experts from California and two from each of the other states.
The group was set up amid claims that the FDA approval process was subject to politicization and may not be transparent, even though the ACIP and FDA’s advisory committee meetings on the vaccine were public.
After conducting a private, concurrent review of the federal process, the workgroup confirmed to the governors of the Western states Dec. 13 that the vaccine is safe and efficacious. In its summary of findings, the workgroup:
- unanimously recommended the use of the Pfizer/Biontech vaccine;
- endorsed the transparency and objectivity of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the ACIP review processes, as well as “the rigor, validity and reliability of their analyses”;
- concluded that the sponsors appropriately considered equity in their clinical trials and urged that “equity continue to be a guiding principle in immunization implementation, monitoring and communication”;
- recommended that the four states avoid undue delay in providing access to the vaccine.
Despite the group’s endorsement of the FDA and ACIP review processes, it will continue to independently review other COVID-19 vaccines coming through the pipeline. The next one on tap is Moderna Inc.’s candidate.
With the FDA’s VRBPAC scheduled to weigh in on Moderna’s vaccine Dec. 17, ACIP has scheduled emergency meetings Dec. 18 and 20 in expectation of a second vaccine EUA.