CureVac

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: 

Pfizer/BioNTech’s Comirnaty appeared to offer only 12% effectiveness against Omicron in children ages 5-11.
  South Africa’s Biovac partnered with nine development institutions to boost local vaccine manufacturing capacity.
  Eli Lilly’s arthritis drug Olumiant reduced the risk of death by 13% in hospitalized Covid-19 patients.   AUTHORIZED VACCINES

 
Pfizer/BioNTech’s Comirnaty is far less protective against infection in children ages…

CureVac has dosed the first participant in a Phase 1 trial of its multivalent mRNA-based seasonal influenza vaccine candidate (CVSQIV) developed with GSK, CureVac announced last week. The companies inked an mRNA collaboration deal in 2020 when GSK invested in the German biopharma.

In other flu news, Cidara Therapeutics announced Monday that the U.S. FDA has accepted its Investigational New Drug (IND) application for the company’s universal influenza antiviral CD388. J&J’s Janssen…

The state of the fight: 

New studies supported heterologous primary regimens and heterologous boosters.
  Serum Institute of India is weighing slashing Covishield production by 50%.
  The U.S. FDA OK’d AstraZeneca’s Evusheld long-acting monoclonal antibody therapy as PrEP for certain groups.

 

AUTHORIZED VACCINES  

Mixing the AstraZeneca/Oxford or Pfizer/BioNTech vaccines with a second dose of Moderna’s shot generated non-inferior immune responses …

The state of the fight: 

A slew of vaccine manufacturers announced plans to tackle the Omicron variant.
  Aspen Pharmacare and J&J neared a deal that would let the South African manufacturer market its own version of the Janssen shot.
  Gavi’s board approved the alliance’s COVAX strategy for 2022.

AUTHORIZED VACCINES  

New research on the Pfizer/BioNTech shot affirmed its efficacy in younger people and its safety in older people.
 
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The state of the fight: 

U.S. regulators signed off on boosters for all adults.
  India raised a syringe export limit to allow supplies to reach PAHO and UNICEF.
  Pfizer will let Medicines Patent Pool sublicense its oral antiviral to manufacturers in 95 countries.

AUTHORIZED VACCINES  
 

Pfizer/BioNTech’s shot generated stronger antibody responses than three rival vaccines. Comirnaty’s performance bested those of the AstraZeneca/Oxford vaccine, the…

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 fight: 

Pfizer/BioNTech’s Comirnaty became the first Covid-19 vaccine to earn full U.S. FDA approval.
  China authorized booster doses for those at high risk of contracting Covid-19.
  Brazil’s Eurofarma Laboratórios will produce Pfizer/BioNTech’s vaccine for exclusive distribution in Latin America.

 

Approved or authorized vaccines

 
British study sees waning protection from shots: The app-based ZOE COVID study (led by a Kings College…

The state of the fight: 

Zydus Cadila’s three-dose, needle-free ZyCoV-D became the first authorized DNA-based Covid-19 vaccine.
  AstraZeneca’s AZD7442 long-acting antibody reduced infection risk by 77% in Phase 3.
  PAHO’s Revolving Fund will begin procuring Covid-19 vaccines for member states. Approved or authorized vaccines

 
Assessing antibody levels to predict Moderna’s effectiveness: Researchers at Seattle’s Fred Hutchinson Cancer Research Center announced…