Pfizer

The U.S. FDA cleared the Investigational New Drug (IND) application for the intranasal RSV vaccine candidate (BLB-201) from Georgia-based CyanVac and its Californian subsidiary, Blue Lake Biotechnology, the companies announced Monday.

The move paves the way for Phase 1 trials, which will test BLB-201 in healthy adults ages 18-75, the press release said.

In other RSV news, Pfizer’s candidate shot (RSVpreF) won U.S. FDA Breakthrough Therapy designation for prevention of RSV in…

The state of the fight: 

Moderna shared new Phase 2/3 data supporting the use of Spikevax in children under age 6.
  Pfizer will supply UNICEF with up to 4 million Paxlovid courses in 2022.
  Boosters of mRNA vaccines continued to offer strong protection against severe Covid-19 outcomes.   AUTHORIZED VACCINES

 
Moderna claimed clinical trial success for its vaccine in children ages 6 months to under 6 years. An interim analysis of Phase 2/3 results showed a “…

The state of the fight: 

Medicines Patent Pool sublicensed Pfizer’s Paxlovid to 35 generics manufacturers.
  Key WTO members reached a tentative agreement to waive some IP rights on Covid-19 vaccines.
  Moderna and Pfizer asked the U.S. FDA to authorize fourth doses of their respective jabs.   AUTHORIZED VACCINES

 
Medigen’s protein subunit vaccine (MVC-COV1901) offered similar safety and immunogenicity for adolescents as it did for adults, the Taipei-based…

The state of the fight: 

Moderna pledged permanently to forgo enforcement of its Covid-19 vaccine patents for shots made “in or for” 92 LMICs.
  Aspen Pharmacare will market an Aspen-branded version of J&J’s vaccine in Africa.
  Fluvoxamine reduced the risk of Covid-19 hospitalization and clinical deterioration by 31% in a meta-analysis.   BOOSTERS

 
A WHO technical advisory group now “strongly supports urgent and broad access” to Covid-19 booster doses…

Pfizer’s C. difficile vaccine candidate (PF-06425090) failed to meet the primary endpoint in a Phase 3 trial, the company announced Tuesday. At final analysis, the shot showed just 31% efficacy at preventing infection after three doses, according to a Pfizer press release. Nonetheless, the jab’s 100% efficacy at preventing “medically attended” infection—a secondary endpoint—suggested a possible future direction for the product, Endpoints News reported.

In more promising news, Pfizer’s…

The state of the fight: 

Pfizer/BioNTech’s Comirnaty appeared to offer only 12% effectiveness against Omicron in children ages 5-11.
  South Africa’s Biovac partnered with nine development institutions to boost local vaccine manufacturing capacity.
  Eli Lilly’s arthritis drug Olumiant reduced the risk of death by 13% in hospitalized Covid-19 patients.   AUTHORIZED VACCINES

 
Pfizer/BioNTech’s Comirnaty is far less protective against infection in children ages…

Fourteen leading pharma companies released fourth-quarter and full-year 2021 financial results in February. (Figures exclude exchange rate and portfolio changes where applicable.)

Leading the pack, SK Bioscience generated an unprecedented $375 million in fourth-quarter revenues—a 573% jump from the same period in 2020—driven by its CMO drug substance manufacturing business, which contributed to AstraZeneca/Oxford and Novavax Covid-19 vaccine production. The South Korean company also…

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: 

Moderna applied for South African patents on its vaccine, potentially jeopardizing the work of the WHO-led mRNA vaccine “hub” operating in the country.
  WHO named five additional African countries that will receive vaccine technology from the hub.
  Laboratorios Farmacéuticos Rovi inked a 10-year mRNA vaccine manufacturing extension with Moderna.   AUTHORIZED VACCINES

                                       
Medigen’s protein subunit…

The state of the fight: 

A Lilly mAb active against Omicron won a U.S. FDA emergency use nod.
  Novavax’s shot proved 80% efficacious in adolescents ages 12-17, according to a Phase 3 readout.
  Vaxxinity’s UB-612 vaccine candidate performed better against Omicron than an mRNA-based comparator jab.

 

AUTHORIZED VACCINES

 
J&J’s single-dose shot was only 53% efficacious against moderate to severe Covid-19 (28 days post-injection) in a final analysis…