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Tuesday, November 24, 2020

What comes next when the COVID-19 vaccines are ready?

Pharmaceutical company Pfizer announced on Nov. 18 that its experimental coronavirus vaccine had “met all of its primary efficacy endpoints.” Pfizer and German partner BioNTech would be applying “within days” to the Food and Drug Administration for an emergency use authorization, which “allow[s] unapproved medical products to be used during a public health emergency when there are no other adequate, approved, or available alternatives.”

Pfizer’s announcement was coupled with news that competitor Moderna has also developed a vaccine that has done well in phase 3 trials, and both have reported an effectiveness of over 94% in preventing COVID-19. It means that we are quickly moving from the “race for the cure” phase of the global pandemic into the “race to deliver it” phase.

How quickly, though, is an open question despite the federal interagency program charged with prodding a vaccine along being fittingly called Operation Warp Speed.

“Before the FDA authorizes any COVID-19 vaccine for emergency use, [an independent scientific review panel called the Vaccines and Related Biological Products Advisory Committee] will review and discuss the data in a publicly-held meeting, likely to be held in December,” Pfizer explained on its website.

Given the “speed it up” manner that has typified the agency’s approach to regulating coronavirus research, that meeting may happen before December. Pfizer reminded anxious readers that the “VRBPAC will provide a recommendation to the FDA on whether or not to authorize the vaccine for emergency use, though the FDA makes the final decision.”

“One or more COVID-19 vaccines may be authorized by FDA for use in December,” predicted Christy Gray, the director of immunization for the Virginia Department of Health.

Alex Berezow is a microbiologist who serves as the vice president of scientific communications for the American Council on Science and Health. He describes the development of a viable coronavirus vaccine in under a year as “blazingly fast.” It isn’t uncommon for vaccines to take a decade or more to develop, test, and win regulatory approval.

Both the Pfizer and Moderna vaccines are RNA-derived vaccines, making the high effectiveness possible but creating logistical problems for transportation and storage. RNA vaccines were not common before the coronavirus pandemic because of those difficulties. The Pfizer vaccine has to be transported and stored in a deep freeze of minus 94 degrees Fahrenheit. The Moderna vaccine can stay stable at the higher but still quite cold temperature of minus 4 degrees Fahrenheit.

Berezow believes that Pfizer’s two-part vaccine will be harder to manage logistically but will be distributed faster and more widely in the United States and Europe because it is backed by the “bigger company” with plenty of previous vaccine experience. “Both are RNA vaccines so that they can scale equally well, but Pfizer probably has more equipment” to manufacture the vaccinations, he said.

Once approval is granted, the federal government has struck an agreement to buy 100 million vaccinations from Pfizer for $1.95 billion, at $19.50 per vaccination.

Different states will have slightly different vaccination plans in cooperation with federal authorities, but there should be considerable overlap. Virginia plans to use a “phased approach” that targets “priority groups.” Gray explained to the Washington Examiner, “Initially, the number of doses available will be limited. … Certain groups, including healthcare workers and those who live in congregate care facilities, may be recommended as a higher priority for receiving a vaccine based on their potential risks for COVID-19.”

All states will have some priorities for who gets vaccinated early on. Some states will likely follow Virginia’s example of also establishing a “health-equity framework” that further rations doses in favor of “underserved and underrepresented individuals,” according to the Oct. 26 interim draft of the state’s COVID-19 Vaccination Plan.

In the early stages, states will not widely disburse the vaccinations. Instead, they will be transported to several facilities in each state. People will have to go to those facilities to get immunized, creating possible bottlenecks. How to handle that is a work in progress. The Centers for Disease Control and Prevention did not respond to the Washington Examiner’s questions about the number of distribution centers per state or their costs by press time.

Pfizer predicts that it could have tens of millions of vaccinations available by the end of this year and produce over a billion vaccines next year. Moderna is projecting about half of Pfizer’s production this year, with promises of more to come. Other vaccines, which are in different stages of testing, will also likely be available next year. The hope, already reflected in huge gains on Wall Street, is that widespread vaccination can finally put the coronavirus lockdowns in the past.

Berezow is also hopeful that this sped-up process will have knock-on effects with the development of other vaccines. However, he admitted that “there aren’t a ton of other diseases we need to vaccinate against in the U.S.”

“More importantly, I’d like to see the development of drugs sped up, like ones for treating cancer or other chronic conditions,” he added.



Read More at Washingtonexaminer

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