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…

Newly revealed data have called into question last year’s exuberant claims from AstraZeneca and Sanofi about nirsevimab, their single-dose monoclonal antibody (mAb) to prevent RSV in infants, Endpoints News reported last week. Published in the New England Journal of Medicine, the Phase 3 data showed that the mAb’s effects on hospitalization were not statistically significant.

Hospitalization is a “key metric” for the potentially lucrative mAb because RSV manifests in most kids “as…

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…

Moderna’s mRNA-based RSV vaccine candidate (mRNA-1345) has advanced to Phase 3 in adults age 60 and older, the Massachusetts-based company announced Tuesday. The U.S. FDA Fast Track-designated shot joins RSV candidates from J&J and Pfizer in late-stage trials. Numerous other vaccine makers are also in the race to bring the first RSV jab to market.

In other RSV news, Enanta Pharmaceuticals last week touted positive Phase 2 data on EDP-938, the Massachusetts-based firm’s N-protein…

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.



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

The state of the fight: 

Moderna and Pfizer/BioNTech launched trials of Omicron-specific vaccine candidates.
  India fully approved SII’s Covishield and Bharat Biotech’s Covaxin shots.
  CEPI tapped BioNet to develop a “variant-proof” pan-coronavirus mRNA-based vaccine.


New data on rates of myocarditis following mRNA-based vaccination trickled in this week, highlighting an increased risk of the heart inflammation side effect in young men…