MPP

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 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: 

WHO issued an Emergency Use Listing for Bharat Biotech’s Covaxin vaccine.
  Kenya’s Revital Healthcare will more than triple its annual syringe production amid a “looming shortfall” in LMICs.
  Pfizer’s Paxlovid antiviral slashed Covid-19 hospitalizations or death by 89%.

 

AUTHORIZED VACCINES

 
WHO listed Bharat Biotech’s Covaxin vaccine for emergency use on Wednesday, citing 78% efficacy against Covid-19 of any severity…

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 “…

The state of the fight: 

Regeneron and Roche’s REGEN-COV became the first antibody drug to score U.S. FDA clearance for post-exposure prophylaxis of Covid-19.
  Six-month data on Pfizer/BioNTech’s vaccine showed continuing high efficacy against severe disease.
  Antibody levels induced by Sinovac’s vaccine dropped sharply six months after completion of a two-dose regimen, according to new data.   Approved or authorized vaccines

New, six-month Pfizer/BioNTech vaccine…

ViiV Healthcare has started a rolling submission for U.S. FDA approval of long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP), the GSK subsidiary announced Tuesday. The U.S. regulator awarded Breakthrough Therapy Designation to the PrEP formulation in November 2020, after Phase 3 data showed that an injection every two months was 89% more effective than Gilead’s daily Truvada (emtricitabine/tenofovir disoproxil fumarate) in preventing HIV acquisition in women.

The TB Alliance announced Tuesday the dosing of the first participant in Phase 1 trials of TBAJ-587, its novel diarylquinoline compound that demonstrated a superior preclinical profile against M. tuberculosis, according to the press release.

In other TB news, the UN-backed Medicines Patent Pool announced last week that it has sublicensed patents and know-how relating to the investigational antibiotic sutezolid to the Gates Medical Research Institute. The sublicense gives access to…

GSK subsidiary ViiV and the UN-backed Medicines Patent Pool announced Monday their signing of a “first-of-its-kind” voluntary licensing agreement to allow four upper-middle-income countries to buy generic versions of HIV regimens containing ViiV’s dolutegravir.

Under the deal terms, “selected generic manufacturers” can supply medicines recommended by WHO or the U.S. Department of Health and Human Services to Azerbaijan, Belarus, Kazakhstan and Malaysia at a “significantly reduced price…