Pfizer vaccine gets FDA review

States, hospitals and others prepare for vaccine shipments to begin within days after FDA advisors review Pfizer vaccine data; experts say states need more help to get vaccines distributed and used

Britain and Canada are ahead of the USA on vaccine clearance but the USA’s turn is about to come. Pfizer’s vaccine gets FDA review Thursday. Moderna’s vaccine gets review next Thursday. At least one more vaccine is expected to be submitted for FDA review in January.

• Two healthcare workers in the UK had allergic reactions to Pfizer’s COVID-19 vaccine. British authorities now warn that those with severe allergies should avoid the new vaccine, but Paul Offit, Director, Vaccine Education Center, Children’s Hospital of Philadelphia and a member of the FDA advisory panel that will review the Pfizer vaccine on Thursday said that warning appears to be overly broad.

  • Offitt says masks are going to be important even after vaccines, because studies have not yet been done to establish whether the vaccines prevent asymptomatic spread of COVID-19. The completed studies only examined whether the vaccines keep people from getting sick or dying.

• COVID-19 has spread so much in the United States that Johnson & Johnson has determined it needs fewer people enrolled in its vaccine clinical trial in order to prove whether it works, STATNews reports. Vaccine trials must be large enough to be sure that people in the study are exposed to the virus.

• Local healthcare professionals telling their own patients about the COVID-19 vaccines will be the most effective way to encourage people to accept the new vaccines, says Noel Brewer, a professor of health behavior at the University of North Carolina Gillings School of Global Public Health.

  • If a person hesitates or is reluctant, ask, “What’s your main concern?” Listen to the answer, then follow-up: “I'd really like you to get this because it will protect you and your family.”

  • The personal endorsement by an individual that people recognize from their community matters more than national leaders, although both are important, says Brewer.

  • Because both the Pfizer and Moderna vaccines require a booster shot 21 or 28 days after the first vaccination, Brewer says people should be required to book their follow-up appointment before getting the first shot or at least “before they get out the door.”

• Ohio had kept COVID-19 somewhat controlled but has suffered from the same surge that has afflicted the entire nation. However, Gov. Mike DeWine’s formerly aggressive approach to the pandemic has given way to milder actions, and the rate of new cases has accelerated dramatically.

• Calculate your risk depending on what kind of room you are in and whether people are sitting, standing, talking or whispering and whether they are wearing masks using this tool by researchers at MIT.

• But understanding how COVID-19 spreads indoors is evolving. The Los Angeles Times reports on a South Korean researcher who determined that the novel coronavirus can infect people from 20 feet away indoors, in certain circumstances.

Tomorrow will be a big day with the FDA advisory panel meeting. Expect the FDA Commissioner to act on the panel’s recommendation very quickly after the meeting ends.