EMA

The state of the fight: 

A booster dose of Bharat Biotech’s Covaxin increased neutralizing antibodies up to 265-fold.
  WHO added therapies from Eli Lilly and GSK/Vir to its list of recommended Covid-19 treatments.
  Novartis will pay over $162 million to in-license Molecular Partners’ ensovibep antiviral candidate.

 

AUTHORIZED VACCINES

Two doses of Pfizer/BioNTech’s vaccine reduced the risk of Covid-19 hospitalization by 94% among adolescents ages 12…

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Pfizer’s 20-valent pneumococcal conjugate vaccine in adults, the company announced last week. Prevnar 20—to be marketed in Europe as Apexxnar—scored its U.S. FDA nod in June.

Pfizer remains locked in a next-gen PCV race with Merck, whose 15-valent shot crossed the regulatory finish line after Pfizer’s in the U.S. but took first place in the E.U.

The state of the fight: 

WHO issued an Emergency Use Listing for Serum Institute of India’s version of Novavax’s vaccine.
  The U.S. CDC recommended mRNA-based vaccines over J&J’s.
  Data on the effectiveness of monoclonal antibody therapies against the Omicron variant began pouring in.

AUTHORIZED VACCINES  

A U.S. CDC advisory panel recommended mRNA-based vaccines over the J&J jab, citing blood clot side effects stemming from the single-dose…

The state of the fight: 

New studies supported heterologous primary regimens and heterologous boosters.
  Serum Institute of India is weighing slashing Covishield production by 50%.
  The U.S. FDA OK’d AstraZeneca’s Evusheld long-acting monoclonal antibody therapy as PrEP for certain groups.

 

AUTHORIZED VACCINES  

Mixing the AstraZeneca/Oxford or Pfizer/BioNTech vaccines with a second dose of Moderna’s shot generated non-inferior immune responses …

The state of the fight: 

A slew of vaccine manufacturers announced plans to tackle the Omicron variant.
  Aspen Pharmacare and J&J neared a deal that would let the South African manufacturer market its own version of the Janssen shot.
  Gavi’s board approved the alliance’s COVAX strategy for 2022.

AUTHORIZED VACCINES  


New research on the Pfizer/BioNTech shot affirmed its efficacy in younger people and its safety in older people.
 

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: 

More European countries cautioned against Moderna’s vaccine for younger people over concerns about side effects.
  Generics companies are preparing to roll out their versions of Merck’s molnupiravir oral antiviral.
  Pfizer is in talks with 90 countries over supply deals for its antiviral candidate.

 

AUTHORIZED VACCINES  


France and Germany recommended against the Moderna vaccine for people under 30 over concerns about…

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 “…

Regulators delivered good news to Merck last week.

Firstly, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the company’s 15-valent pneumococcal conjugate vaccine in adults. The U.S. FDA approved the shot in July.

Meanwhile, the FDA approved Merck’s blockbuster cancer immunotherapy, Keytruda, to be used in combination with chemotherapy, with or without bevacizumab (Roche’s Avastin), for the treatment of patients with persistent, recurrent…

The state of the fight: 

A U.S. FDA advisory panel recommended booster shots of the J&J and Moderna vaccines for select groups.
  CureVac will abandon development of its first-generation mRNA-based vaccine candidate.
  Brii Bio has submitted its monoclonal antibody cocktail to the U.S. FDA for Emergency Use Authorization. Approved or authorized vaccines

 
WHO advisory group backs extra dose for immunocompromised: WHO’s Strategic Advisory Group of Experts (…