To Boost Or Not To Boost? Pfizer, FDA, And The COVID Vaccine Communication Challenge

Pfizer’s bid for third dose appears to get pushback from the US government, but reticence about the booster may reflect PR considerations more than any fundamental concern about the vaccine.

Pfizer Inc.’s announcement that that it would be seeking authorization for a booster shot to its COVID vaccine raises a host of challenges for the US government, from what criteria it will use to evaluate the application, to how it will communicate with the public about the issue.

Health officials have long acknowledged the near inevitability of boosters. (Also see "US Gov't Plans To Control COVID Vaccine...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

US FDA Meeting Drought Ends … With A Vengeance

 

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.