U.S. Food and Drug Administration advisers endorsed Pfizer’s COVID-19 vaccine for emergency use.
If approved by the FDA, the emergency use authorization would allow shipments of the drug to be sent out within 24-hours of the announcement.
The vaccine still needs approval from FDA career staff and to be vetted by a Centers for Disease Control and Prevention advisory council before it can be administered, according to state health officials.
Juneau expects its first shipment of vaccine doses to arrive next week, said Robert Barr, City and Borough of Juneau Emergency Operations Center planning section chief, Thursday in an email.
The state is still waiting on recommendations from the CDC’s Advisory Committee on Immunization Practices, said Dr. Anne Zink, Alaska’s chief medical officer, during a Thursday news conference. ACIP has yet to schedule a meeting to issue formal guidelines but is expected to do so soon.
The backing from the FDA’s Vaccines and Related Biological Products Advisory Committee comes on the same day Gov. Mike Dunleavy announced he will issue a third disaster declaration for the coronavirus pandemic. The disaster declaration will last for 30 days and ending Jan. 15, 2021, according to the governor’s office.
“While the first shipment of the COVID-19 vaccine is expected to arrive in Alaska any day now, the threat posed by the virus is still with us,” Dunleavy said in a news release. “We can see the light at the end of the tunnel — but the next 30 days are crucial to advance therapeutic treatments and the vaccination plan so we can defeat this virus and begin returning to normal.”
Juneau health officials are expecting fewer than 1,000 doses of the vaccine in the first shipment. The doses will be distributed to frontline health care workers and long-term care patients among other select groups. The state’s three-phase distribution model is based on ACIP recommendations, and while guidelines have been issued for the first part of the first phase, Zink said health officials are still waiting on the committee for further guidance.
The dosses expected to arrive are only one part of a two-dose vaccine and will require a follow-up injection to be sent by the federal government in the coming weeks. Health officials said at a previous news conference it is critical people receive their second injection exactly as prescribed by the company. For Pfizer’s vaccine that means a second injection exactly 21 days after the first. Another vaccine from Moderna is expected to go through the same process with the FDA next week, and that vaccine requires the second dose after 28 days.
Barr said shipments would go first to Anchorage and then be distributed throughout the state. Pfizer’s vaccine needs to be stored at extremely cold temperatures, and the company is providing its own shipping containers that can store the drug for more than two weeks.
Bartlett Regional Hospital has an ultra-cold storage freezer, Barr said, as does the Alaska Department of Fish and Game where the vaccine will be stored.
The first shipments coming to Juneau are not likely to meet the community’s need, Barr said Tuesday during a community meeting, but more shipments will soon follow. On Thursday Zink noted that federal organizations such as the Department of Veterans Affairs and the Department of Defense would be receiving their own shipments in the state as well.
Health officials have said the vaccine’s effectiveness depends how many people are willing to take it. Pfizer’s vaccine was developed in less than a year, but Zink said in a previous news conference the drug was based on pre-existing research and had been thoroughly vetted.
The vaccine has already been approved and administered in the U.K. and Canada with few side effects reported. Following reports of allergic reactions among health workers, U.K. regulators Wednesday issued an advisory for anyone with a history of strong allergic reactions to forgo the vaccine for now, BBC reported.
According to The AP, Pfizer representatives said they have seen no signs of allergic reactions in their trial. But some of the FDA advisers fear the British warning will deter millions of Americans with allergies who might benefit from the COVID-19 vaccine from giving it a try, and urged additional studies to try to settle the issue, The AP reported.
Pfizer has said it will have about 25 million doses of the two-shot vaccine for the U.S. by the end of December, according to The AP. But the initial supplies will be reserved primarily for health care workers and nursing home residents, with other vulnerable groups next in line until ramped-up production enables shots to become widely available on-demand, The AP reported, something that will probably not happen until the spring.
Zink and other state health officials have repeatedly said there is no intention at the state level to mandate the vaccine. Vaccine mandates can’t be required while the drug remains under emergency use authorization, Zink said during an Alaska Senate committee meeting Monday.
The state set up a new website, covidvax.alaska.gov, with information on the vaccine and Alaska’s distribution plan.