CureVac

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.
 

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…

FierceBiotech reported Monday that CureVac quietly revealed in its latest financial report that Boehringer Ingelheim is walking away from its $600 million lung cancer deal inked with the German mRNA maker in 2014.

The new setback for CureVac comes just two months after its Covid-19 mRNA shot showed only 47% efficacy at preventing any severity of the disease, the news outlet said.

The state of the hunt: 

India authorized Moderna’s shot.
  Zydus Cadila applied for authorization in India of its DNA-based vaccine, which proved 67% effective in Phase 3.
  Five Indian generics manufacturers will conduct a joint trial of Merck’s molnupiravir antiviral.


Editor’s note: The Covid-19 R&D round-up will be on hiatus next week. Please look for our next issue on Friday, July 16.

 

Approved or authorized vaccines

Iran granted…

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…