vaccines

A booster dose of Sanofi’s Dengvaxia tetravalent dengue vaccine “does not elicit a consistent, meaningful booster effect” against all dengue serotypes in people previously exposed to the virus, according to a Phase 2 non-inferiority study published Tuesday in The Lancet Infectious Diseases.

The Sanofi-funded study—conducted in Colombia and the Philippines—tested an additional dose of the live attenuated shot administered one or two years after a two- or three-dose primary series in…

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…

China’s National Medicinal Products Administration has approved Walvax’s bivalent HPV vaccine for the prevention of cervical cancer caused by HPV 16 and HPV 18, Chinese media sources reported last week.

The shot will compete for domestic market share against GSK, Merck, and China’s Xiamen Innovax.

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 “…

Bavarian Nordic has entered into a licensing and supply agreement with Shanghai-based Nuance Pharma to develop and commercialize Bavarian’s RSV vaccine candidate (MVA-BN RSV) for adults in China and other Asian markets, the Danish company announced Monday. Under the deal, Nuance Pharma will pay $12.5 million upfront and up to $212.5 million in milestones.

Nuance will run Phase 1 and 3 trials in China and push Asian regulatory approval for the vaccine, according to the press release.

A month after stepping down as president of Takeda’s global vaccine business, Rajeev Venkayya has been named CEO of Aerium Therapeutics, an antibody specialist that emerged from stealth mode on Tuesday. The Boston- and Lausanne-based biopharma’s pipeline includes two monoclonal antibodies against SARS-CoV-2 aimed at “vulnerable populations for which vaccines do not provide adequate protection,” according to a press release.

Leaving Takeda after a decade, Venkayya told Reuters that with…

Serum Institute of India (SII) will boost its European presence through a vaccine manufacturing tie-up between its Serum Life Sciences subsidiary and Mumbai-based Wockhardt, the latter announced Sunday.

Wockhardt’s U.K. subsidiary will set up a new fill-finish facility in North Wales capable of producing 150 million doses of “multiple” SII vaccines, the press release said. Financial terms were not disclosed.

Pune-based SII established Serum Life Sciences in the U.K. in October…

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 U.S. National Institute of Allergy and Infectious Diseases (NIAID) has dosed the first participant in a Phase 1 trial of a trio of mRNA-based vaccines against HIV, according to a press release Monday from the U.S. National Institutes of Health.

Manufactured by Moderna through a NIAID-backed contract, each of the three candidates in the mRNA-1574 vaccine program encodes for “different but highly related, stabilized proteins” of HIV, the press release said. The U.S.-based study seeks…

Mentions:

The University of Oxford has started recruiting for a Phase 1/2 human challenge trial of a paratyphoid vaccine candidate, the university announced last week. The University of Maryland School of Medicine developed the oral candidate (CVD 1902) to protect against Salmonella Paratyphi infection, per the press release.

An Oxford researcher commented that a licensed paratyphoid vaccine is “desperately needed” due to “increasing antibiotic resistance.”