BBIL

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: 

The vaccine candidate from Novavax demonstrated 90.4% overall efficacy in Phase 3—and 93% against “key variants.”
  CureVac’s mRNA vaccine candidate performed poorly, missing the primary endpoint in a Phase 3 trial riddled with variant infections.
  The U.S. launched a $3 billion program to stimulate antiviral drug R&D. Approved or authorized vaccines

European regulators over the past week gave mixed signals on the safety profile of…

Iranian state-run news reported Wednesday that Tehran’s Pasteur Institute and India’s Bharat Biotech have agreed to cooperate on a technology transfer that will allow Iran to produce the Indian company’s rotavirus vaccine. The article didn’t reveal any further details about the deal.

The state of the hunt: 

China authorized Sinovac’s vaccine for children as young as age 3.
  The U.S. will reportedly divert $2 billion from COVAX to pay Pfizer/BioNTech for doses it intends to donate.
  Merck entered a $1.2 billion deal to supply an investigational antiviral to the U.S., pending a regulatory nod.   Approved or authorized vaccines

China cleared Sinovac’s CoronaVac jab for youths ages 3 to 17, becoming the first country to offer Covid-19 vaccines to…

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: 

Moderna’s vaccine showed high efficacy in adolescents.
  U.S. regulators cleared a monoclonal antibody from GSK and Vir for emergency use.
  Sanofi and GSK launched the Phase 3 trial of their vaccine candidate.   Approved or authorized vaccines

Moderna touts data for teens: Less than two months after Pfizer and BioNTech boasted of their mRNA-based jab’s 100% efficacy in adolescents, Moderna shared almost identical news. The Massachusetts-…

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”…