Gavi

The state of the fight: 

Regeneron and Roche’s REGEN-COV became the first antibody drug to score U.S. FDA clearance for post-exposure prophylaxis of Covid-19.
  Six-month data on Pfizer/BioNTech’s vaccine showed continuing high efficacy against severe disease.
  Antibody levels induced by Sinovac’s vaccine dropped sharply six months after completion of a two-dose regimen, according to new data.   Approved or authorized vaccines

New, six-month Pfizer/BioNTech vaccine…

The state of the fight: 

Gavi inked a 550-million-dose supply deal with China’s CNBG and Sinovac.
  Bharat Biotech applied for WHO Emergency Use Listing of its inactivated vaccine.
  Cuba authorized BioFarmaCuba’s Abdala vaccine.

 

Approved or authorized vaccines

The U.S. FDA granted Priority Review to Pfizer/BioNTech’s Comirnaty vaccine in the companies’ bid for full licensure, the companies announced Friday.
 
While the press release noted a…

The state of the hunt: 

Gavi plans new terms and conditions for self-financing COVAX participants.
  Cuba’s three-dose Abdala vaccine candidate proved 92.3% effective in Phase 3.
  The U.S. halted distribution of two monoclonal antibodies from Eli Lilly.

 

Approved or authorized vaccines

Bharat Biotech submitted final Phase 3 data to Indian regulators showing 77.8% efficacy for its Covaxin vaccine, local media reported Tuesday.
 
In other news on…

The state of the hunt: 

WHO cleared Sinovac’s vaccine for emergency use.
  Gavi’s COVAX AMC funding summit exceeded its goals, securing $2.4 billion in commitments.
  India ordered 300 million doses of a yet-to-be-authorized Bio E vaccine candidate. Approved or authorized vaccines

Sinovac’s inactivated vaccine notched WHO Emergency Use Listing on Monday, leaving the shot, CoronaVac, eligible for supply through the COVAX Facility. Less-demanding storage requirements…

The state of the hunt:

J&J, Moderna and Pfizer/BioNTech pledged to provide 3.5 billion vaccine doses to LMICs at low cost.
  Sanofi touted favorable interim Phase 2 results for its protein-based vaccine candidate.
  Serum Institute of India pushed back its timeline to resume exporting vaccine doses to COVAX.

 

Approved or authorized vaccines

 
India’s review of bleeding and clotting events following immunization found a minuscule risk of those…

The state of the hunt:

A trial of Bharat Biotech’s vaccine in children age 2-18 advanced to Phase 2/3.
  China authorized its sixth vaccine.
  The United States started vaccinating adolescents age 12-15 with Pfizer/BioNTech’s shot.

 

Vaccines


Approved or authorized vaccines
  
The U.S. FDA expanded its authorization of Pfizer/BioNTech’s Covid-19 vaccine on Monday to children age 12-15, a move one FDA official called a “critical step”…

The state of the hunt:

WHO issued Emergency Use Listing for the inactivated vaccine from CNBG’s Beijing subsidiary.
  Pfizer and BioNTech applied for full U.S. FDA approval of their Comirnaty vaccine.
  Moderna and Novavax inked supply deals with COVAX for at least 850 million combined doses.

 

Vaccines


Approved or authorized vaccines
   
WHO listed the BBIBP-CorV vaccine from CNBG’s Beijing subsidiary for emergency use on Friday,…

The state of the hunt:

Pfizer/BioNTech asked the U.S. FDA to expand its authorization of their vaccine to adolescents.
  Numerous countries restricted the use of the AstraZeneca/Oxford shot to older people—or discontinued it altogether—even as regulators concluded the benefits outweighed the risks.
  COVAX affirmed that SII’s supply commitments to the initiative remain “legally binding” amid continued export restrictions from India.

 

Vaccines


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…

Médecins Sans Frontières (MSF), Save the Children, UNICEF and WHO issued a press release last week welcoming the addition of GSK’s rotavirus vaccine, Rotarix, to their Humanitarian Mechanism, which allows civil society organizations in countries not otherwise eligible for Gavi support to buy shots at manufacturers’ lowest available price for use in emergencies.

Founded in 2017, the Humanitarian Mechanism was previously limited to pneumococcal conjugate vaccines (from GSK and Pfizer).…