BioNTech

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…

Germany’s BioNTech announced Monday that it is “evaluating sustainable mRNA vaccine production capacities in Africa” for a candidate malaria shot and other vaccines.

The company said in a press release it would select promising candidates for clinical development from “multiple vaccines featuring known [m]alaria targets” (such as the circumsporozoite protein) while also evaluating new antigens. First trials are planned for year-end 2022.

In the same press release, BioNTech said…

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…

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 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…

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…

The state of the hunt: 

China authorized Sinovac’s vaccine for children as young as age 3.
  The U.S. will reportedly divert $2 billion from COVAX to pay Pfizer/BioNTech for doses it intends to donate.
  Merck entered a $1.2 billion deal to supply an investigational antiviral to the U.S., pending a regulatory nod.   Approved or authorized vaccines

China cleared Sinovac’s CoronaVac jab for youths ages 3 to 17, becoming the first country to offer Covid-19 vaccines to…

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…