Pharmaniaga

The state of the hunt:

The European Union and India made new moves to curtail vaccine exports.
  COVAX warned of delivery delays.
  Pfizer and BioNTech launched a pediatric trial of their vaccine in children as young as 6 months.

 

Vaccines


Approved or authorized vaccines
   
New data, new questions for AstraZeneca: If AstraZeneca thought higher-than-expected efficacy results this week from the U.S.-based Phase 3 trial of AZD1222 would…

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…

The state of the hunt:

Novavax’s protein-based vaccine candidate demonstrated 89.3% efficacy in a UK Phase 3 trial.
  J&J/Janssen’s single-dose vaccine was 66% effective against moderate to severe disease in Phase 3.
  Vaccines from J&J, Moderna, Novavax and Pfizer/BioNTech appear less effective against the SARS-CoV-2 variant first identified in South Africa.

 

Vaccines


Approved or authorized vaccines

AstraZeneca/Oxford’s…

The state of the hunt:

India inked vaccine supply deals with Bharat Biotech and SII.
  BioNTech upped its 2021 production target for Comirnaty to 2 billion doses—but the Pfizer/BioNTech vaccine faced near-term production slowdowns and delivery lags.
  An African Union-backed supply initiative locked up 270 million vaccine doses for the continent.

 

Vaccines


Approved or authorized vaccines

Sinovac’s inactivated jab notched its first…

The state of the hunt:

The United Kingdom issued emergency authorization of Pfizer/BioNTech’s vaccine.
  WHO is reviewing the Pfizer/BioNTech shot for Emergency Use Listing.
  Moderna requested emergency nods for its mRNA-based vaccine from the U.S. FDA and the European Medicines Agency.

 

Vaccines


Approved or authorized vaccines

Pfizer is now seeking full British marketing authorization for its Covid-19 vaccine “in parallel” with the…

Institute of India (SII) has spun off its Covid-19 vaccine portfolio into a new company, per local media.

According to its website, Serum Institute Life Sciences will “leverage Serum Institute’s current manufacturing capabilities” and has begun construction of a new, billion-dose-capacity GMP facility. The company currently has five Covid-19 vaccines in its pipeline, including two developed in-house and three more from partnerships with AstraZeneca, Codagenix and Novavax.

In…

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,…

Reuters reported last week that Indonesia will postpone its October deadline for halal compliance for food, drugs and cosmetics amid concerns that industry will not be able to meet the target date, which could lead to a ban on many life-saving vaccines.

According to the article, the head of Indonesia’s International Pharmaceutical Manufacturing Group said that drug and vaccine manufacturers might have until 2026 to comply, however, even that might “not be enough.”

Since 2017,…

Local media reported this week that Indonesia’s top national Muslim clerical body has issued a fatwa allowing measles-rubella (MR) immunization despite traces of pig DNA that it found in the vaccine.

“The use of the MR vaccine from the Serum Institute of India, for the time being, is permissible,” the head of Majelis Ulama Indonesia was quoted as saying; the vaccine is allowable because of lack of a halal alternative and the dangers to children of missing immunization.

Local…

Local media reported this week that state-backed Pharmaniaga has picked Malaysia’s northern peninsula to build the country’s first halal vaccine plant.

Managing Director Datuk Farshila Emran was quoted as saying the new plant is expected to be completed between 2020 and 2022, with the first commercial vaccine batches set to be introduced two years later.

Media reported last year that Pharmaniaga will start by producing halal versions of meningococcal vaccine and diphtheria,…