Healthcare workers and first responders, followed by people with underlying medical conditions and older adults in congregate settings, like nursing homes, should be first in line to get the COVID-19 vaccine when it is available, U.S. scientific and medical advisers urged.
The advice came in a Sept. 1 draft framework being constructed by a panel of experts from the U.S. National Academies of Sciences, Engineering and Medicine. They are developing the framework for allocating the COVID-19 vaccine at the request of the National Institutes of Health and the Centers for Disease Control and Prevention.
Providing recommendations about vaccine allocation typically has been the job of the CDC's Advisory Committee on Immunization Practices, or ACIP, which has held three virtual meetings on the matter, most recently on Aug. 26.
The National Academies said its framework is intended to inform the COVID-19 plans of the CDC's ACIP and state, local, tribal and territorial authorities.
The National Academies' final report is due later this fall, the group stated. The scientific organization plans to hold an online public forum Sept. 2 to gain input on the draft allocation report, which lays out a four-phase strategy.
Allocating vaccine doses
The White House's Operation Warp Speed project has awarded six contracts for the production of COVID-19 vaccines: $1.53 billion to Moderna Inc. for 100 million doses; $1 billion to Johnson & Johnson for 100 million doses; $2.1 billion to Sanofi and GlaxoSmithKline PLC for 100 million doses; $1.95 billion to Pfizer Inc. for 100 million doses; $1.6 billion to Novavax Inc. for 100 million doses; and $1.2 billion to AstraZeneca PLC for 300 million doses.
Even if one or more safe and effective COVID-19 vaccines are tested and quickly approved for use, they are unlikely to be available immediately in amounts sufficient to vaccinate the whole population, despite large-scale production of the products already underway before trials are completed, the National Academies committee said in its draft report.
"As a result, at the outset and in the months to follow, vaccines will almost certainly be available only in limited supplies," the experts wrote.
Therefore, the COVID-19 vaccines may need to be allocated in ways that reduce virus transmission or reduce morbidity and mortality to protect the public's health and socioeconomic well-being, they said.
Other phases
After the COVID-19 vaccine has reached the highest-priority groups, the plan's second phase calls for critical workers in industries essential to the functioning of society and at substantially high risk of exposure to the virus to get the shot. That group would include teachers and school staff and people in homeless shelters or group homes.
Also included in the second phase are people in prisons, jails, detention centers and similar facilities, and any staff who work in those settings. In addition, all other older people and adults with moderate underlying health conditions not included in the first phase would get the vaccine in the second stage.
The third round of people in line for the vaccine would consist of young adults, children and workers with a moderate risk of acquiring infection.
The fourth phase would include everyone else who has not yet been vaccinated once the supply of the COVID-19 vaccine is more broadly available.
In each phase of the allocation plan, especially the first, the number of people may exceed the amount of vaccine that is available, and therefore authorities should make best efforts to complete each stage before proceeding to the next, the National Academies panel noted. Making mid-course corrections will need to be the rule rather than the exception, the experts said.
Moving too fast
Some in the scientific and public health communities have raised concerns that the development and regulatory processes for a COVID-19 vaccine are moving too fast. U.S. Food and Drug Administration Commissioner Stephen Hahn has come under fire for saying he was willing to put a COVID-19 vaccine on the U.S. market under an emergency use authorization, or EUA, before late-stage human trials are completed.
Hahn also said the decision for a COVID-19 vaccine EUA could come by election day on Nov. 3 — a highly unusual public prediction for a U.S. regulator to make about any experimental product under his jurisdiction.
The FDA chief has also been criticized for making misleading and false remarks about the efficacy of convalescent plasma in treating COVID-19 — a product for which Hahn's agency granted an EUA on Aug. 23.
On Sept. 1, an NIH advisory committee said in new treatment guidelines that there are insufficient data to recommend the use of convalescent plasma in COVID-19.
"Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19," the NIH expert panel stated.