Xiamen Innovax’s bivalent HPV vaccine has won WHO prequalification, PATH announced Tuesday.

The quality mark allows UNICEF and other international agencies to buy the shot—and breaks Merck’s and GSK’s hold over Gavi supply.

PATH—which provided technical assistance to China-based Innovax during the WHO review process—is also sponsoring a Phase 3 trial (underway in Bangladesh and Ghana) to evaluate regimens of the shot with fewer doses.

Japan’s Global Health Innovative Technology Fund announced $21 million in product development investments on Wednesday.

More than two-thirds of the awards will help advance six ongoing projects, while the rest fund four new investments: a leishmaniasis drug from Takeda and the Drugs for Neglected Diseases initiative; a malaria therapy from Eisai, the Medicines for Malaria Venture and the University of Dundee; a tuberculosis drug from Daiichi Sankyo RD Novare and the TB Alliance; and a…

The state of the hunt:

Russia’s Sputnik V vaccine has reportedly been authorized in 26 countries.
  SAGE recommended that all countries proceed with planned rollouts of the AstraZeneca/Oxford jab, while the Africa CDC offered more cautious guidance, amid reports of low efficacy against viral variants.
  Tanzania has no plans to mount a Covid-19 immunization campaign.



Approved or authorized vaccines

SAGE backs AZ jab…

Bharat Biotech (BBIL), GSK and PATH issued a joint press release Wednesday announcing a technology transfer of GSK’s RTS,S malaria shot to the Hyderabad-based vaccine manufacturer.

The agreement transfers manufacturing of the RTS,S antigen and grants all rights to the malaria vaccine to BBIL, while GSK will continue to produce and supply the shot’s AS01E adjuvant.

GSK, development partner PATH and WHO have been looking for a long-term manufacturer in the event that ongoing…


The state of the hunt:

WHO issued its first EUL for a Covid-19 vaccine in recent days while Britain and the EMA authorized an additional jab and China and India cleared their first shots.
  Both Bharat Biotech and Pfizer claimed their respective vaccines are effective against newly identified SARS-CoV-2 variants.
  SII pledged to sell an initial 100 million doses to India at a “special price” of $2.74 each.



Approved or authorized…

PATH will collaborate with China-based diagnostics specialist Wondfo to create a new point-of-care glucose-6-phosphate dehydrogenase (G6PD) deficiency test, the Seattle nonprofit announced Tuesday. The test would guide the appropriate clinical care of people with P. vivax malaria who also have the hereditary enzyme deficiency.

Because the 8-aminoquinoline drugs normally used to treat P. vivax malaria can cause severe anemia in people with G6PD deficiency, WHO considers G6PD testing “…


PATH announced last week that it will conduct post-licensure Phase 3 trials of Xiamen Innovax’s bivalent human papillomavirus vaccine, Cecolin, to boost evidence for future WHO prequalification (PQ). The studies, testing different regimens against Merck’s Gardasil, are planned for the fourth quarter in Bangladesh and Ghana.

WHO accepted the shot for review in March, two months after Chinese regulators approved it.

Innovax said in June that it expects to begin supplying “…


The state of the hunt:

Serum Institute of India is reportedly pursuing up to $1 billion in private equity funding for its Covid-19 vaccine projects.
  J&J plans 60,000-participant Phase 3 trials of its Janssen subsidiary’s vaccine candidate.
  Roche will help develop and manufacture Regeneron’s REGN-COV2 antibody cocktail, more than tripling production capacity of the drug.



Phase 3 trials:
Brazil approved Phase 3…

PATH announced last month that the West African Health Organization has prequalified Chlorxy-G gel for umbilical cord care to prevent newborn sepsis. PATH is leading the introduction and scale-up of the chlorhexidine digluconate gel, which is manufactured by Nigeria-based Drugfield Pharmaceuticals, the press release said.

Also last month, PATH announced results of a Science Translational Medicine study that identified two markers of immunity induced by the RTS,S/AS01 malaria vaccine.…

The state of the hunt: 

Moderna received U.S. FDA clearance to proceed with Phase 2 studies of its investigational vaccine, mRNA-1273, as it continues accelerating its development program. Moderna also moved up the targeted launch of Phase 3 to “early summer,” after saying as recently as April 16 that it hoped to begin in the fall. Japan’s Pharmaceuticals and Medical Devices Agency issued an emergency approval of Gilead’s remdesivir yesterday.