FDA

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 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: 

Oral antivirals from Pfizer and Merck notched U.S. FDA authorizations.
  Earlier use of remdesivir cut the risk of death or hospitalization by 87% in a new study.
  The Novavax vaccine secured a second WHO Emergency Use Listing.

AUTHORIZED VACCINES  

The AstraZeneca/Oxford vaccine starts waning in protection against serious illness within three months of the second dose, according to cohort studies in Brazil and Scotland published…

The U.S. FDA has awarded Orphan Drug Designation to Zydus Cadila’s malaria therapeutic, the company announced last week.

The status gives the Ahmedabad-based drugmaker eligibility for “certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval,” the press release said.

Zydus Cadila is developing the potential single-dose ZY19489 (MMV253) radical cure for P.…

ViiV has won U.S. FDA approval for Apretude, the first long-acting injectable for pre-exposure prophylaxis of HIV, the GSK subsidiary announced Monday.

The cabotegravir-based shot can be administered as few as six times per year after the first two 600-mg doses, per the press release. In clinical trials, Apretude offered 69%-90% lower incidences of HIV when compared to daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) tablets.

The FDA nod gives the injectable…

Mentions:

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 U.S. FDA has granted priority review to Merck’s 15-valent pneumococcal conjugate vaccine (PCV) as the agency evaluates the shot for children and adolescents ages 6 weeks to 17 years, the company announced Wednesday.

Marketed as Vaxneuvance, the jab won FDA approval for use in adults in July, just weeks after Pfizer’s 20-valent vaccine became the first next-gen PCV to cross the finish line.

VBI Vaccines has secured a U.S. FDA nod for what the company calls the “only” approved three-antigen adult hep B shot in the country, according to a Wednesday press release.

Marketed as PreHevbrio, the recombinant vaccine elicited higher rates of seroprotection in Phase 3 than GSK’s single-antigen Engerix-B in all adults (91.4% vs. 76.5%) and adults ages 45 and older (89.4% vs. 73.1%), the Massachusetts-based company said.

The vaccine is approved for use and commercially…