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…

A new U.S. FDA approval adds adolescents to the population eligible for Cabenuva, the long-acting injectable HIV-1 treatment combining ViiV’s cabotegravir and Janssen’s rilpivirine, J&J announced Tuesday. Like adults, virologically suppressed adolescents age 12 and older can take the combo either monthly or every two months.

In related news, GSK subsidiary ViiV announced a Cabenuva label update last week. The FDA-approved update eliminates a mandatory oral lead-in with cabotegravir…

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…

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…

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…

Bavarian Nordic’s RSV vaccine candidate (MVA-BN RSV) has notched U.S. FDA Breakthrough Therapy designation for adults age 60 and older on the strength of preliminary clinical evidence, the Denmark-based company announced Monday. The news follows earlier Phase 2 data showing the candidate resulted in a “statistically significant” reduction of viral load and up to 79% efficacy in preventing symptomatic RSV infections in adults ages 18-50.

The company said it plans to start a Phase 3…

CureVac has dosed the first participant in a Phase 1 trial of its multivalent mRNA-based seasonal influenza vaccine candidate (CVSQIV) developed with GSK, CureVac announced last week. The companies inked an mRNA collaboration deal in 2020 when GSK invested in the German biopharma.

In other flu news, Cidara Therapeutics announced Monday that the U.S. FDA has accepted its Investigational New Drug (IND) application for the company’s universal influenza antiviral CD388. J&J’s Janssen…

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: 

South Africa’s Afrigen has produced the first batch of its version of Moderna’s mRNA-based vaccine.
  Afrigen also secured a $45 million grant from the U.N.-backed Medicines Patent Pool.
  Moderna’s Spikevax notched full approval in the U.S.


Pfizer and BioNTech have begun rolling data submission for authorization of their Comirnaty shot in children between ages 6 months and 5 years “at the request” of the U.S…