Biovac

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…

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…

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:

Moderna began clinical trials of its vaccine in children.
  New vaccines from Iran and Vietnam entered human trials, and a Cuban shot reached Phase 3.
  France limited use of AstraZeneca’s vaccine to people 55 or older.

 

Vaccines


Approved or authorized vaccines
  
AZ jab is safe, EMA reaffirms—but will uptake suffer? A European Medicines Agency (EMA) risk assessment committee concluded a preliminary review…

Johannesburg’s University of the Witwatersrand will collaborate with Cape Town’s Biovac, helping the South African government-backed biopharma “build specialist skills capacity” to produce viral-vectored vaccines, the university announced last week.

Through Wits Enterprise—a private company owned by the university—an academic team specializing in adenovirus-vectored vaccines will train Biovac to generate engineered viruses for possible use against Covid-19 and other diseases, per the…

The state of the hunt:

COVAX has inked a deal for up to 40 million doses of Pfizer/BioNTech’s vaccine.
  India launched its mass vaccination campaign against Covid-19.
  China and India are both giving away vaccine doses to their neighbors.

 

Vaccines


Approved or authorized vaccines
 
China’s Sinovac jab more effective using three-week interval: A silver lining has emerged to last week’s middling news from the Butantan Institute’s…

South Africa’s government-backed Biovac has yet to complete a technology transfer with Sanofi for its acellular hexavalent vaccine, a local media interview with the biotech’s CEO revealed last week. When Biovac announced the Sanofi agreement in July 2019, it said it would begin manufacturing hexa by the third quarter of this year. Instead, the technology transfer process remains ongoing, albeit “at an advanced stage,” per IOL.

Mentions:

The state of the hunt:

Novavax brought its vaccine candidate to Phase 2.
  WHO reportedly offered wealthier countries new, more flexible terms for the COVAX Facility.
  The U.S. FDA expanded the Emergency Use Authorization for Gilead’s Veklury (remdesivir).

 

Vaccines

Phase 3 candidates:
 
Pfizer and BioNTech have enrolled more than half of the 30,000 people they seek for U.S.-based Phase 3 trials of their mRNA Covid-19 vaccine candidate,…

The Developing Countries Vaccine Manufacturers Network (DCVMN) announced last week its new executive committee, elected in October of last year at its annual meeting in Rio de Janeiro.

Its seven voting members are Bharat Biotech International Limited’s Sai Prasad (India), Biovac’s Patrick Tippoo (South Africa), Butantan’s Tiago Rocca (Brazil), China National Biotec Group’s Lingjiang Yang, Sinergium’s Fernando Lobos (Argentina), Innovax’s Wendy Huang (China), and Bio Farma’s…

Local media reported this week that South Africa’s Biovac has won an 85 percent share of a $770 million government vaccines contract. Biovac will provide BCG, measles-containing and hep B shots, as well as Pfizer’s Prevnar 13 pneumococcal conjugate vaccine and Sanofi’s Hexaxim acellular hexavalent vaccine. GSK will supply the country’s human papillomavirus and rotavirus vaccines.

Business Day said the 3.5-year award ends months of uncertainty about Biovac’s future, which started after…