Bio E

The state of the fight: 

Medicines Patent Pool sublicensed Pfizer’s Paxlovid to 35 generics manufacturers.
  Key WTO members reached a tentative agreement to waive some IP rights on Covid-19 vaccines.
  Moderna and Pfizer asked the U.S. FDA to authorize fourth doses of their respective jabs.   AUTHORIZED VACCINES

 
Medigen’s protein subunit vaccine (MVC-COV1901) offered similar safety and immunogenicity for adolescents as it did for adults, the Taipei-based…

The state of the fight: 

India granted Biological E’s Corbevax—a low-cost, patent-free vaccine—its first regulatory authorization.
  A J&J booster was 85% effective against hospitalization in South Africa during the Omicron wave.
  India authorized molnupiravir but omitted the antiviral from its recommended clinical protocol on safety concerns.

 

AUTHORIZED VACCINES

 
Bharat Biotech’s Covaxin generated “superior antibody responses” in children…

The state of the fight: 

Merck will allow Medicines Patent Pool to sublicense its oral antiviral to manufacturers in 105 LMICs.
  The Access to COVID-19 Tools Accelerator released a new strategic plan and budget through September 2022.
  Antidepressant fluvoxamine reduced the risk of hospitalization for high-risk Covid-19 patients by about 32%. Approved or authorized vaccines

 
Two pediatric doses of Moderna’s mRNA-based vaccine given 28 days apart produced a “…

The state of the fight: 

A U.S. FDA advisory panel recommended booster shots of the J&J and Moderna vaccines for select groups.
  CureVac will abandon development of its first-generation mRNA-based vaccine candidate.
  Brii Bio has submitted its monoclonal antibody cocktail to the U.S. FDA for Emergency Use Authorization. Approved or authorized vaccines

 
WHO advisory group backs extra dose for immunocompromised: WHO’s Strategic Advisory Group of Experts (…

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: 

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 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…

WHO awarded prequalification (PQ) status last week to Biological E’s Typhibev typhoid conjugate vaccine (TCV).

Typhibev becomes the second TCV to receive the designation: fellow Hyderabad-based drugmaker Bharat Biotech won PQ for its Typbar-TCV in 2017.

Correction: This story has been updated to correct the year Typbar-TCV won WHO prequalification status. It 2017, not 2018. 

 

Mentions:

The Developing Country Vaccine Manufacturers Network (DCVMN) touted this week that three of its Indian member companies have registered their WHO prequalified products simultaneously in eight sub-Saharan countries using the health organization’s collaborative registration procedure (CRP).

Geneva-based DCVMN—which is holding its annual meeting this week in a remote format—said that Bharat Biotech, Biological E and Serum Institute of India had leveraged CRP’s information sharing process…

The state of the hunt:

Gavi made a preliminary deal with GSK and Sanofi, securing up to 200 million doses of their vaccine candidate for the COVAX Facility.
  British regulators began expedited reviews of vaccines from AstraZeneca and Pfizer, and South Korea also began an initial review of the AstraZeneca candidate.
  A trial of an investigational Lilly mAb failed against advanced Covid-19 cases, and a trial of a Regeneron mAb cocktail in people requiring high-flow…