vaccines

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…

University of Oxford researchers on Wednesday launched a Phase 1 trial of an adenoviral-vectored vaccine candidate for human plague. Forty healthy adults ages 18-55 will receive the new shot, which is based on the same ChAdOx1 platform used for the AstraZeneca/Oxford Covid-19 vaccine, according to a press release from the university.

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GSK used its second-quarter 2021 results, released Wednesday, to announce the abandonment of a Phase 2 pediatric RSV vaccine candidate after results showed the shot (GSK3389245A/ChAd155-RSV) was unlikely to meet target efficacy. The company also has adult and maternal immunization candidates for RSV in Phase 3.

Nonetheless, the U.S. FDA did hand GSK a good start to the week: on Monday, the agency expanded the market for Shingrix, approving the blockbuster shot for the prevention of…

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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…

Batavia Biosciences announced last week that it has successfully manufactured shots for Phase 1 trials in Africa and the U.S. of the recombinant vesicular stomatitis virus (rVSV) vector-based Lassa fever vaccine being developed by the International AIDS Vaccine Initiative (IAVI).

The Dutch company, which initially partnered with IAVI in 2018, said it manufactured rVSVΔG-LASV-GPC using its HIP-Vax platform, which “enables the production of high volumes of vaccine doses in a small…

Merck’s next-generation 15-valent pneumococcal conjugate vaccine (PCV) earned U.S. FDA approval in adults last week, crossing the finish line for people age 18 and older nearly six weeks after rival Pfizer’s 20-valent shot.

Even so, Merck’s Vaxneuvance seems poised to beat Pfizer in the race for the lucrative pediatric market. Merck said in May that it plans to seek FDA approval for the shot’s use in children this year.

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Sinovac announced last week that China’s National Medical Products Administration has approved its Sabin-based inactivated polio vaccine (sIPV).

In its press release, the Chinese biotech said that WHO accepted its prequalification materials in early 2020 and completed site inspections this February. If prequalified, Sinovac’s sIPV would become the second Sabin-based product to gain the status after LG Chem’s in January 2021.

The Beijing Institute of Biological Products and…

Local media reported Monday that Mumbai-based TechInvention has struck an import deal with EuBiologics to market the South Korean company’s oral cholera vaccine (OCV) in India.

Business Standard quoted TechInvention CEO Syed Ahmed as saying the move fills a market gap resulting from Sanofi’s OCV production pause at its Shantha subsidiary. TechInvention is targeting a price range for Euvichol-Plus of $8-$10 per single dose in India’s private market, according to the article. The company…

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…