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World No. 1 Or US No. 3? Global Access May Factor Into US Booster Shot Decision

 
• By Derrick Gingery

A third shot of COVID-19 vaccine may be recommended for Americans soon, but the CDC says the best defense against the pandemic in the US includes ensuring the entire world gets the primary series.

Third vaccine booster dose
Boosters are on the 24 August meeting agenda for the CDC's vaccine advisors. • Source: Alamy

Boosters may be inevitable for the US coronavirus vaccination effort, but federal officials will have to weigh global issues, as well as their own data, in deciding when to recommend a third shot.

The push for requiring a booster shot for those who received the two-shot mRNA vaccine from Pfizer Inc./BioNTech...

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More from Vaccines

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 
• By Sarah Karlin-Smith

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

HHS mRNA Vaccine Funding Cut Impact Limited (And One Contract Isn’t Even mRNA)

 
• By Alaric DeArment

HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.

Vaccine Developers To Benefit From CEPI’s ‘World First’ Adjuvant ‘Matchmaking’ Service

 
• By Eliza Slawther

Selected vaccine developers will soon be able to use a new adjuvant “matchmaking” initiative that could help create more “effective, potent” vaccines against epidemic and pandemic threats, the Coalition for Epidemic Preparedness Innovations has said.

More from Pink Sheet

Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review

 
• By Lisa Takagi

While Japanese government announces 8-15% price cuts for four drugs, including Leqembi, industry groups urge operational improvements to national cost effectiveness assessment scheme.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.