BioE

The state of the hunt:

Moderna’s mRNA-based vaccine secured Emergency Use Listing from WHO.
  Merck entered voluntary licensing agreements with five Indian drugmakers for its investigational antiviral molnupiravir.
  Biological E’s subunit vaccine candidate advanced to Phase 3.

 

Vaccines


Approved or authorized vaccines
    
WHO granted Moderna’s vaccine Emergency Use Listing on Friday, according to a press release from the…

Colorado-based diagnostics firm InDevR announced last week the commercial launch of its VaxArray measles and rubella (MR) antigen quantification kit. The MR vaccine potency test measures antigen content in five hours—a “fraction” of the 10-14 days needed for conventional tissue culture infectious dose measurement—potentially reducing the cost per dose of the final vaccine, according to the press release.

InDevR developed the Gates Foundation-funded product in collaboration with…

The state of the hunt:

The AstraZeneca/Oxford vaccine secured its first authorizations.
  Novavax launched a 30,000-participant North American Phase 3 trial for its recombinant vaccine.
  CNBG claimed 79% efficacy for the inactivated jab from its Beijing subsidiary but provided scant data.

 

Vaccines


Approved or authorized vaccines
 
UK authorizes AstraZeneca/Oxford jab: Britain’s Medicines and Healthcare products Regulatory Agency…

Seoul’s International Vaccine Institute (IVI) announced Thursday that SK Bioscience’s Vi-DT typhoid conjugate vaccine (TCV) has met the primary endpoints in Phase 3 trials in Nepal.

The diphtheria toxoid-based candidate induced an immune response that was non-inferior to Bharat Biotech International Limited’s WHO-prequalified Typbar-TCV and was shown to be safe in all 1,350 participants (ages 6 months to 45 years).

IVI, which developed the Vi-DT vaccine, transferred the…

The state of the hunt:

Moderna’s became the second Covid-19 vaccine to receive U.S. FDA Emergency Use Authorization.
  COVAX has secured nearly 2 billion doses of vaccines but faces a “very high” failure risk, according to Reuters.
  Canada, Saudi Arabia and the United States have begun immunization campaigns using Pfizer/BioNTech’s jab.

 

Vaccines


Approved or authorized vaccines
 
The U.S. FDA granted Emergency Use Authorization (EUA…

The state of the hunt:

Pfizer/BioNTech’s vaccine won U.S. FDA Emergency Use Authorization.
  The inactivated vaccine from CNBG’s Beijing subsidiary secured UAE registration.
  Bharat Biotech and SII requested Indian authorization of their respective jabs.

 

Vaccines


Approved or authorized vaccines
 
The Pfizer/BioNTech vaccine extended its regulatory lead this week with new authorizations, including a U.S. nod.
 
The U.S.…

The state of the hunt:

Pfizer and BioNTech submitted a U.S. FDA Emergency Use Authorization request for their vaccine.
  Lilly’s rheumatoid arthritis drug Olumiant snagged an EUA (in combo with remdesivir) as a Covid-19 treatment.
  WHO formally issued a conditional recommendation against using Gilead’s remdesivir in hospitalized Covid-19 patients.

 

Vaccines


Phase 3 candidates

Pfizer/BioNTech request EUA: Friday’s submission to the U…

The Developing Countries Vaccine Manufacturers Network announced last month that it has launched an international consortium to assess replacing the standard mouse protection test with the pertussis serological potency test (PSPT) for batch testing whole-cell pertussis vaccines.

Members of the project—funded by a $750,000 grant from the U.S. National Institute for Innovation in Manufacturing Biopharmaceuticals—include Bharat Biotech, Bio Farma, Biological E, BB-NCIPD, Central Drugs…

Hyderabad-based Biological E. Limited (BioE) used the opening of a new vaccine plant this week to announce that Indian authorities have approved its single-dose typhoid conjugate vaccine (TCV) for people 6 months and older.

According to the press release, the company anticipates WHO prequalification this year for the vaccine. GSK’s Italy-based Vaccines Institute for Global Health originated the shot, transferring it to BioE in 2013 for subsequent development and clinical trials.

Mentions:

The Developing Countries Vaccine Manufacturers Network (DCVMN) announced last week its new executive committee, elected in October of last year at its annual meeting in Rio de Janeiro.

Its seven voting members are Bharat Biotech International Limited’s Sai Prasad (India), Biovac’s Patrick Tippoo (South Africa), Butantan’s Tiago Rocca (Brazil), China National Biotec Group’s Lingjiang Yang, Sinergium’s Fernando Lobos (Argentina), Innovax’s Wendy Huang (China), and Bio Farma’s…