CEPI

The state of the fight: 

South Africa’s Biovac will fill-finish the Pfizer/BioNTech vaccine.
  The U.S. will give $200 million to South Africa’s Aspen Pharmacare to boost vaccine capacity.
  CEPI and IVI are backing new vaccine trials in Africa.

 

Regulatory updates

Sanofi’s “Vidprevtyn” under rolling review: The EMA announced Tuesday it has begun reviewing the recombinant protein Covid-19 vaccine candidate, which uses a GSK adjuvant. Sanofi also expects real…

Batavia Biosciences announced last week that it has successfully manufactured shots for Phase 1 trials in Africa and the U.S. of the recombinant vesicular stomatitis virus (rVSV) vector-based Lassa fever vaccine being developed by the International AIDS Vaccine Initiative (IAVI).

The Dutch company, which initially partnered with IAVI in 2018, said it manufactured rVSVΔG-LASV-GPC using its HIP-Vax platform, which “enables the production of high volumes of vaccine doses in a small…

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 International AIDS Vaccine Initiative (IAVI) announced Monday $27.4 million in additional funding to conduct Phase 2b trials of its recombinant vesicular stomatitis virus (rVSV) vector-based Lassa fever vaccine (rVSVΔG-LASV-GPC) in Liberia, Nigeria and Sierra Leone.

According to the press release, the European & Developing Countries Clinical Trials Partnership and the Coalition for Epidemic Preparedness Innovations (CEPI) provided the grant, which builds on an earlier $10.4…

Mentions:

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:

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…

Belgium-based biomanufacturing platform company Univercells announced Tuesday that it has signed letters of intent with two Senegal-based organizations to strengthen local vaccine manufacturing capacity. The company will work with the Institute for Health Research, Epidemiological Surveillance and Training to strengthen its R&D capabilities and create bioproduction capacity for routine immunization vaccines, and will also partner with Institut Pasteur de Dakar to rapidly establish local…

The state of the hunt:

Pfizer and BioNTech plan to seek authorization of their vaccine for adolescents age 12-15 after promising Phase 3 results.
  J&J agreed to supply up to 400 million doses of Janssen’s jab to the African Union.
  Serum Institute of India launched clinical trials of its version of the Novavax vaccine candidate.

 

Vaccines


Approved or authorized vaccines
   
New data show lower efficacy for Pfizer/BioNTech: The…

The state of the hunt:

Moderna began clinical trials of its vaccine in children.
  New vaccines from Iran and Vietnam entered human trials, and a Cuban shot reached Phase 3.
  France limited use of AstraZeneca’s vaccine to people 55 or older.

 

Vaccines


Approved or authorized vaccines
  
AZ jab is safe, EMA reaffirms—but will uptake suffer? A European Medicines Agency (EMA) risk assessment committee concluded a preliminary review…