Finlay Institute

The state of the fight: 

New studies supported heterologous primary regimens and heterologous boosters.
  Serum Institute of India is weighing slashing Covishield production by 50%.
  The U.S. FDA OK’d AstraZeneca’s Evusheld long-acting monoclonal antibody therapy as PrEP for certain groups.

 

AUTHORIZED VACCINES  

Mixing the AstraZeneca/Oxford or Pfizer/BioNTech vaccines with a second dose of Moderna’s shot generated non-inferior immune responses …

The state of the fight: 

A slew of vaccine manufacturers announced plans to tackle the Omicron variant.
  Aspen Pharmacare and J&J neared a deal that would let the South African manufacturer market its own version of the Janssen shot.
  Gavi’s board approved the alliance’s COVAX strategy for 2022.

AUTHORIZED VACCINES  


New research on the Pfizer/BioNTech shot affirmed its efficacy in younger people and its safety in older people.
 

The state of the fight: 

More European countries cautioned against Moderna’s vaccine for younger people over concerns about side effects.
  Generics companies are preparing to roll out their versions of Merck’s molnupiravir oral antiviral.
  Pfizer is in talks with 90 countries over supply deals for its antiviral candidate.

 

AUTHORIZED VACCINES  


France and Germany recommended against the Moderna vaccine for people under 30 over concerns about…

The state of the fight: 

A U.S. regulatory committee endorsed booster doses for vulnerable people and those over age 65.
  Kenya outlined plans to start fill-finish production of Covid-19 shots in early 2022.
  An SII subsidiary scooped up a 15% stake in Biocon’s biologics unit as the companies launched a strategic alliance to produce and commercialize vaccines. Approved or authorized vaccines

 
A new substudy in The Lancet supports flexible schedules for the…

The state of the hunt:

The European Union and India made new moves to curtail vaccine exports.
  COVAX warned of delivery delays.
  Pfizer and BioNTech launched a pediatric trial of their vaccine in children as young as 6 months.

 

Vaccines


Approved or authorized vaccines
   
New data, new questions for AstraZeneca: If AstraZeneca thought higher-than-expected efficacy results this week from the U.S.-based Phase 3 trial of AZD1222 would…

The state of the hunt:

Serum Institute of India will export Covishield doses to the United Kingdom.
  COVAX unveiled initial vaccine allocations, and numerous COVAX participants received their first shipments and began administering jabs.
  Bharat Biotech’s Covaxin demonstrated 81% efficacy against symptomatic disease in an interim Phase 3 analysis.

 

Vaccines


Approved or authorized vaccines
  
U.S. regulators completed their signoff…

The state of the hunt:

Two versions of the AstraZeneca/Oxford vaccine secured EUL from the World Health Organization.
  J&J has applied for both WHO and EMA authorization for Janssen’s Covid-19 vaccine.
  The Pfizer/BioNTech shot remains stable at higher temperatures than previously believed.

 

Vaccines


Approved or authorized vaccines
 
Pfizer and BioNTech are testing their vaccine in pregnant women through a 4,000-participant…

The state of the hunt:

India inked vaccine supply deals with Bharat Biotech and SII.
  BioNTech upped its 2021 production target for Comirnaty to 2 billion doses—but the Pfizer/BioNTech vaccine faced near-term production slowdowns and delivery lags.
  An African Union-backed supply initiative locked up 270 million vaccine doses for the continent.

 

Vaccines


Approved or authorized vaccines

Sinovac’s inactivated jab notched its first…

The state of the hunt:

China will join the COVAX Facility, its foreign ministry announced Thursday.
  Regeneron requested U.S. FDA emergency authorization for a monoclonal antibody cocktail, and Eli Lilly planned a similar request for its mAb cocktail in November. 
  Remdesivir showed expanded benefits in final Phase 3 results published in the New England Journal of Medicine.

 

Vaccines

Phase 3 candidates:
 
The European Medicines Agency…

The state of the hunt:

Novavax brought its vaccine candidate to Phase 2.
  WHO reportedly offered wealthier countries new, more flexible terms for the COVAX Facility.
  The U.S. FDA expanded the Emergency Use Authorization for Gilead’s Veklury (remdesivir).

 

Vaccines

Phase 3 candidates:
 
Pfizer and BioNTech have enrolled more than half of the 30,000 people they seek for U.S.-based Phase 3 trials of their mRNA Covid-19 vaccine candidate,…