On Thursday, the FDA’s vaccine review committee, formally known as the Vaccines and Related Biological Products Advisory Committee, recommended approval of the COVID-19 vaccine developed by Pfizer and BioNTech.
“The U.S. Food and Drug Administration has informed the sponsor [Pfizer and BioNTech] that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” according to a statement by the FDA.
The Vaccines and Related Biological Products Advisory Committee will review the vaccine made by Moderna next Thursday, Dec. 17. Hawaii is on target to begin vaccinating people early next week, dependent on further approvals and information from the CDC relative to the agency’s final recommendations for the priority in which vaccines should be given. In a discussion this morning with Lt. Gov. Dr. Josh Green with New West Broadcasting’s Sherry Bracken, Green said the state does not have to adhere to the CDC’s specific priority guidelines, but does want to follow through with the review process and ensure all the approvals are in place prior to beginning innoculating people.
Between the two vaccines, by the end of the month Hawaii is slated to get 81,000 doses, according to State Health Director Libby Char, speaking at a Thursday press conference. Dr. Char said the State will get a second shipment for the second dose in about a month, so 81,000 people will get vaccinated. The plan now is to offer vaccinations first to front line health care workers, staff and residents of long-term care facilities, and first responders and essential workers. In today’s discussion, Lt. Gov. Green said there are around 6 vaccines that should be approved within the next several months, and he expects the vaccines to flow to the state regularly. Regarding neighbor islands, Green said there will be no problem in vaccine shipment, storage, or delivery. North Hawaii Community Hospital, Hilo Medical Center, and Kona Community Hospital are prepared to receive the vaccines and can store both the Pfizer/BioNTech and the Moderna vaccines at super cold (-70 to -94 degree) temperatures as needed. Although hospitals will be the first to receive and do the vaccinating, Hilton Raethel of the Healthcare Association of Hawaii said CVS, Walgreens, other pharmacies, local health clinics, Kaiser, and other partners will take part in helping all people who want it get vaccinated.
Lt. Gen. Kenneth Hara of the Hawaii Emergency Management Agency (HIEMA), Incident Commander for the State, says HIEMA and the National Guard have been in discussions since April, and intensively since September, about vaccine distribution. National Guard members will be involved in assisting with distribution as needed.
The EUAs are not full approval of the vaccines. The manufacturers are required to continue to submit safety and efficacy data to the FDA. It usually takes 3 to 7 months for full approval. Green said people need to get both doses to get the 94% immunity demonstrated in the clinical trials, so even those who have been vaccinated still need to wear masks until the population achieves herd immunity, with around 70% or more of the people getting vaccinated. Green, who has had COVID-19, said those who have had it probably do not need to get a vaccine within the first 90 days of having it, but that even those who had COVID-19 should get vaccinated. But he noted that CDC guidance will continue to be issued as more is known and more people get vaccinated.
To watch Gov. David Ige’s Thursday press conference about Hawaii’s vaccination plans, with Lt. Gov. Dr. Josh Green, Department of Health Director Dr. Libby Char, and Lt. Gen. Kenneth Hara of the Hawaii Emergency Management Agency, click here.
