Moderna

The state of the fight: 

Regeneron and Roche’s REGEN-COV became the first antibody drug to score U.S. FDA clearance for post-exposure prophylaxis of Covid-19.
  Six-month data on Pfizer/BioNTech’s vaccine showed continuing high efficacy against severe disease.
  Antibody levels induced by Sinovac’s vaccine dropped sharply six months after completion of a two-dose regimen, according to new data.   Approved or authorized vaccines

New, six-month Pfizer/BioNTech vaccine…

Moderna announced last week its launch of a foundation to promote “public health, healthcare and educational opportunities,” with an initial endowment of $50 million. The Moderna Charitable Foundation is the first public social good commitment for the maker of the blockbuster Covid-19 vaccine.

Meanwhile, Novartis last week announced a 10-year collaboration with multiple U.S.-based historically Black colleges and universities (HBCUs) and HCBU medical schools to co-create programs that…

Mentions:

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…

Moderna announced Wednesday that it has launched a Phase 1/2 study of mRNA-1010—its quadrivalent seasonal influenza vaccine candidate—in healthy adults in the United States.

The news follows Sanofi’s report last month that it has also begun Phase 1 trials of an mRNA-based candidate targeting A/H3N2 flu. BioNTech and Pfizer are also working on an mRNA-based flu candidate.

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Swedish CDMO Recipharm announced Tuesday that it will build a fill-finish facility in Morocco to supply vaccines and biotherapeutics in Africa by 2023. According to the press release, the Moroccan government and local banks will invest around $500 million to support the project.

FiercePharma reported that the facility will have an annual capacity of about 300 million units.

In other Recipharm news, Moderna announced last week that its Monts, France site has begun drug product…

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: 

Gavi plans new terms and conditions for self-financing COVAX participants.
  Cuba’s three-dose Abdala vaccine candidate proved 92.3% effective in Phase 3.
  The U.S. halted distribution of two monoclonal antibodies from Eli Lilly.

 

Approved or authorized vaccines

Bharat Biotech submitted final Phase 3 data to Indian regulators showing 77.8% efficacy for its Covaxin vaccine, local media reported Tuesday.
 
In other news on…

Health science conglomerate Danaher will acquire North Dakota-based CDMO Aldevron for approximately $9.6 billion in cash, the former announced last week. Aldevron, which manufactures plasmid DNA, mRNA and recombinant proteins for companies including Moderna, will operate as a standalone business within Danaher’s Life Sciences segment, the press release said. Danaher’s holdings include diagnostics specialists Cepheid and Beckman Coulter as well as a biologics manufacturing unit the Washington…

WHO announced Monday that the COVAX partnership’s first Covid-19 mRNA vaccine technology transfer hub will launch with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a “network of universities,” and the Africa Centres for Disease Control and Prevention.

A press release quoted WHO Director-General Tedros Adhanom Ghebreyesus as saying Covid-19 had “highlighted the importance of local production to address health emergencies,” while South Africa’s…

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…