Bio Farma

The state of the hunt:

Pfizer and BioNTech plan to seek authorization of their vaccine for adolescents age 12-15 after promising Phase 3 results.
  J&J agreed to supply up to 400 million doses of Janssen’s jab to the African Union.
  Serum Institute of India launched clinical trials of its version of the Novavax vaccine candidate.

 

Vaccines


Approved or authorized vaccines
   
New data show lower efficacy for Pfizer/BioNTech: The…

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:

Two versions of the AstraZeneca/Oxford vaccine secured EUL from the World Health Organization.
  J&J has applied for both WHO and EMA authorization for Janssen’s Covid-19 vaccine.
  The Pfizer/BioNTech shot remains stable at higher temperatures than previously believed.

 

Vaccines


Approved or authorized vaccines
 
Pfizer and BioNTech are testing their vaccine in pregnant women through a 4,000-participant…

The state of the hunt:

WHO issued its first EUL for a Covid-19 vaccine in recent days while Britain and the EMA authorized an additional jab and China and India cleared their first shots.
  Both Bharat Biotech and Pfizer claimed their respective vaccines are effective against newly identified SARS-CoV-2 variants.
  SII pledged to sell an initial 100 million doses to India at a “special price” of $2.74 each.

 

Vaccines


Approved or authorized…

The state of the hunt:

The Pfizer/BioNTech vaccine received several new authorizations, including from the European Union.
  Canada joined the U.S. in authorizing Moderna’s jab. .
  Argentina and Belarus became the first countries outside Russia to OK Sputnik V.

 

Vaccines


Approved or authorized vaccines
 
Pfizer and BioNTech will market their BNT162b2 vaccine in the European Union under the brand name Comirnaty after receiving…

The state of the hunt:

The efficacy of AstraZeneca’s AZD1222 vaccine candidate may reach 90%, but critics questioned the reported results.
  New, more detailed data on Russia’s Sputnik V vaccine indicates 91.4% efficacy.
  Regeneron’s mAb cocktail secured U.S. FDA Emergency Use Authorization.

 

Vaccines


Phase 3 candidates

AstraZeneca’s two-shot vaccine regimen showed 90% efficacy when given at a lower dose and 62% efficacy as two full…

WHO applied its new Emergency Use Listing (EUL) procedure to a vaccine for the first time last week, enabling countries to deploy novel type 2 oral polio vaccine (nOPV2) to combat circulating vaccine-derived poliovirus outbreaks, the press release said.

The Bio Farma-produced shot is genetically stable compared to traditional OPV2, according to the Global Polio Eradication Initiative, which also said Bio Farma is preparing 160 million doses for deployment before the end of the year.…

The state of the hunt:

Gavi made a preliminary deal with GSK and Sanofi, securing up to 200 million doses of their vaccine candidate for the COVAX Facility.
  British regulators began expedited reviews of vaccines from AstraZeneca and Pfizer, and South Korea also began an initial review of the AstraZeneca candidate.
  A trial of an investigational Lilly mAb failed against advanced Covid-19 cases, and a trial of a Regeneron mAb cocktail in people requiring high-flow…

The state of the hunt:

The U.S. FDA approved Gilead’s Veklury (remdesivir) for hospitalized Covid-19 patients 12 and older.
  IAVI, Merck and Serum Institute of India will collaborate to develop anti-SARS-CoV-2 monoclonal antibodies they plan to make accessible to LMICs.
  AstraZeneca resumed U.S. Phase 3 trials of its AZD1222 Covid-19 vaccine candidate.

 

Vaccines

Phase 3 candidates:
 
J&J is “preparing to resume recruitment” for the…

The state of the hunt:

Remdesivir showed “little or no effect” on 28-day mortality or the duration of hospital stay among hospitalized Covid-19 patients, according to data from a WHO study.
  J&J paused all dosing in trials involving its Janssen subsidiary’s vaccine candidate.
  Pfizer will not apply for U.S. FDA Emergency Use Authorization for its mRNA Covid-19 vaccine candidate before the third week of November.

 

Vaccines

Phase 3 candidates:…