CDC

The state of the fight: 

Sanofi and GSK’s vaccine candidate demonstrated 58% efficacy against symptomatic Covid-19 in Phase 3.
  Hetero Pharma’s generic version of Merck’s molnupiravir reduced the risk of hospitalization by over 65%.
  Britain and Japan pledged a combined $514 million to CEPI’s pandemic preparedness plan.   AUTHORIZED VACCINES

 
The U.S. FDA lifted its clinical hold on Bharat Biotech’s Covaxin, clearing the way for the inactivated vaccine to…

The state of the fight: 

South Africa’s Afrigen has produced the first batch of its version of Moderna’s mRNA-based vaccine.
  Afrigen also secured a $45 million grant from the U.N.-backed Medicines Patent Pool.
  Moderna’s Spikevax notched full approval in the U.S.

REGULATORY UPDATES

 
Pfizer and BioNTech have begun rolling data submission for authorization of their Comirnaty shot in children between ages 6 months and 5 years “at the request” of the U.S…

The state of the fight: 

India granted Biological E’s Corbevax—a low-cost, patent-free vaccine—its first regulatory authorization.
  A J&J booster was 85% effective against hospitalization in South Africa during the Omicron wave.
  India authorized molnupiravir but omitted the antiviral from its recommended clinical protocol on safety concerns.

 

AUTHORIZED VACCINES

 
Bharat Biotech’s Covaxin generated “superior antibody responses” in children…

The state of the fight: 

U.S. regulators signed off on boosters for all adults.
  India raised a syringe export limit to allow supplies to reach PAHO and UNICEF.
  Pfizer will let Medicines Patent Pool sublicense its oral antiviral to manufacturers in 95 countries.

AUTHORIZED VACCINES  
 

Pfizer/BioNTech’s shot generated stronger antibody responses than three rival vaccines. Comirnaty’s performance bested those of the AstraZeneca/Oxford vaccine, the…

The state of the fight: 

Merck will allow Medicines Patent Pool to sublicense its oral antiviral to manufacturers in 105 LMICs.
  The Access to COVID-19 Tools Accelerator released a new strategic plan and budget through September 2022.
  Antidepressant fluvoxamine reduced the risk of hospitalization for high-risk Covid-19 patients by about 32%. Approved or authorized vaccines

 
Two pediatric doses of Moderna’s mRNA-based vaccine given 28 days apart produced a “…

Both Pfizer’s and Merck’s next-generation pneumococcal conjugate vaccines (PCVs) got the nod for routine use from the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) last week.

The decision surprised Wall Street analysts, who had expected ACIP to favor Pfizer’s single-dose 20-valent Prevnar “one-and-done” vaccine over Merck’s 15-valent Vaxneuvance (which requires the company’s 23-valent polysaccharide Pneumovax as a booster), according to FiercePharma.

Both…

The state of the fight: 

The U.S. FDA set a September date to discuss Pfizer/BioNTech boosters while E.U. officials saw “no urgent need” for boosters in the already vaccinated.
  Recruitment started in India for a late-stage trial of Serum Institute of India’s Covovax in children, and Biological E won approval to study its Corbevax in children.
  Prehospital antiplatelet therapy (such as aspirin) was associated with significantly lower in-hospital mortality in some…

The state of the fight: 

Multiple wealthy countries outlined imminent booster dose plans, spurning a WHO plea for patience.
  Novavax pushed back its timeline for seeking U.S. FDA authorization for its vaccine and said the U.S. had paused funding for the shot’s production.
  The African Vaccine Acquisition Trust announced its first shipments of doses.

 

Approved or authorized vaccines

 
J&J’s shot offers up to 96.2% protection against death,…

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:

Serum Institute of India will export Covishield doses to the United Kingdom.
  COVAX unveiled initial vaccine allocations, and numerous COVAX participants received their first shipments and began administering jabs.
  Bharat Biotech’s Covaxin demonstrated 81% efficacy against symptomatic disease in an interim Phase 3 analysis.

 

Vaccines


Approved or authorized vaccines
  
U.S. regulators completed their signoff…