In a surprise move, the U.S. Centers for Disease Control and Prevention has scheduled an emergency meeting of its outside scientific advisers for Dec. 1 to vote on which groups of Americans should receive the limited initial doses of the COVID-19 vaccines once those products are cleared for the U.S. market.
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The CDC had intended to wait to hold an urgent gathering of its Advisory Committee on Immunization Practices, or ACIP, until after the U.S. Food and Drug Administration granted an emergency use authorization, or EUA, to a COVID-19 vaccine.
Moncef Slaoui, chief scientific adviser for the White House's Operation Warp Speed public-private partnership, has said he anticipates the FDA to make a decision on the EUA application from Pfizer Inc. and BioNTech SE within hours after the agency's Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meets Dec. 10. The FDA is planning to hold a similar VRBPAC meeting Dec. 17 to examine the COVID-19 vaccine data from Moderna Inc. and its partner the National Institute of Allergy and Infectious Diseases, or NIAID — a date the company confirmed Nov. 30.
At the ACIP's Nov. 23 virtual meeting, CDC officials said they did not expect to again convene the agency's panel of outside advisers until at least after the FDA's VRBPAC met on Dec. 10.
But on Nov. 27, the CDC posted a notice on its website stating that emergency ACIP meeting would now take place well ahead of the VRBPAC session and any FDA decision.
Last week, Health and Human Service Secretary Alex Azar said the Trump administration may not wait for the ACIP's COVID-19 allocation recommendations before the federal government starts shipping doses once the FDA gives the all clear.
The CDC did not respond to questions about whether Azar's remarks triggered the agency's decision to bring the ACIP together in another virtual session sooner than it initially anticipated.
On Dec. 1, the ACIP members are expected to vote on whether the 21 million U.S. healthcare personnel and 1.3 million residents of long-term care facilities, like nursing homes and assisted living facilities, should be first in line for the COVID-19 shots — phase 1a of the vaccination program.
If both the Pfizer-BioNTech and Moderna-NIAID vaccines are granted EUAs in December, there are expected to be only enough doses by the end of 2020 to vaccinate about 20 million people in the U.S., with more doses not coming for the other 310 million Americans until later.
HHS signed a deal in mid-October with CVS Health Corp. and Walgreens Boots Alliance Inc. to administer COVID-19 vaccines at U.S. long-term care facilities.
A number of ACIP members at the Nov. 23 meeting also said essential workers should be included in the next priority round — phase 1b — to get the COVID-19 shots.
However, Azar said under the Trump administration's plan, U.S. states and territories will ultimately decide who gets the vaccines and are not required to take the ACIP's advice — a patchwork strategy philanthropist Bill Gates called dysfunctional.
The earlier vote by the ACIP will now give U.S. states and territories more time to consider the CDC panel's recommendations.
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Biden adds more pandemic advisers
Meanwhile, President-elect Joe Biden and Vice President-elect Kamala Harris have expanded their COVID-19 Advisory Board, adding three more members to the panel: Seattle nurse Jane Hopkins; Jill Jim, executive director at Navajo Nation Department of Health; and epidemiologist and George Washington University professor David Michaels.
Biden established the team of COVID-19 advisers on Nov. 9 and met with them for the first time later the same day to discuss the incoming administration's strategy for tackling the pandemic.
The Biden-Harris transition team got its first look inside the Trump administration's COVID-19 operation last week.
NIAID Director Anthony Fauci, who met last week with Ronald Klain, Biden's chief of staff, said Nov. 29 on NBC's "Meet the Press" that the U.S. may see a surge of COVID-19 cases a few weeks into December "superimposed" on the current surge. He made similar remarks on ABC's "This Week."
Canadian action may thwart Trump
Canada took a major step late last week to stop drugs from being exported in bulk from the country into the U.S. by wholesalers and pharmacies under a program created by the Trump administration.
The Canadian government and the U.S. drug industry have long opposed the Trump administration's drug importation program, which goes into effect Nov. 30 under a rule finalized in late September.
Canadian Health Minister Patty Hajdu issued an order Nov. 27 prohibiting certain prescription medicines intended for her country's market from being distributed for consumption outside that nation if that sale would cause or worsen a drug shortage. Drug companies are required under the order to provide information to assess existing or potential shortages when requested and within 24 hours if there is a serious or imminent health risk.
Last week, groups representing the brand-name drug industry filed a lawsuit in the U.S. District Court for the District of Columbia challenging the Trump administration's final rule — a legal battle that was expected.
HHS has acknowledged it has been unable to estimate any cost savings from drug importation.