UNITAID

Unitaid will fund “two large-scale operational projects” distributing long-acting injectable HIV pre-exposure prophylaxis (PrEP) to at-risk populations in Brazil and South Africa, the WHO-hosted agency announced last week.

ViiV Healthcare—recently under fire for its reluctance to pursue voluntary licensing for the cabotegravir-based shots—will donate supplies. But the donation didn’t exempt the GSK subsidiary from pricing scrutiny from Unitaid’s executive director, who publicly urged…

Mentions:

Washington D.C. lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) is "attacking the WHO" and several governments it accuses of "harming biopharma innovation," Endpoints News reported Wednesday.

In its annual update to the U.S. Trade Representative on the state of IP protection, PhRMA singled out a WHO roadmap for access to medicines and vaccines, faulting the document for urging technical support to countries that pursue compulsory licensing. Notwithstanding…

GSK issued a press release Wednesday welcoming WHO’s new recommendation for widespread use of the company’s RTS,S malaria vaccine among children in sub-Saharan Africa and other regions with moderate to high P. falciparum transmission.

The shot disappointed in a 2009-2014 trial, showing only 39% efficacy against clinical malaria. But new Phase 3 results in August demonstrated that seasonal RTS,S vaccination in combination with chemoprevention reduced uncomplicated malaria by 63% and…

The Clinton Health Access Initiative (CHAI), Hyderabad-based Laurus Labs and Unitaid announced a deal Monday to accelerate the development, commercialization and registration of a generic version of J&J/Janssen’s fixed-dose combination HIV treatment darunavir/ritonavir (DRV/r) for children.

Laurus Labs gets a “financial incentive” for a portion of the development and commercialization costs for the second- and third-line treatment, the joint press release said, without giving…

The state of the fight: 

Regeneron and Roche’s REGEN-COV became the first antibody drug to score U.S. FDA clearance for post-exposure prophylaxis of Covid-19.
  Six-month data on Pfizer/BioNTech’s vaccine showed continuing high efficacy against severe disease.
  Antibody levels induced by Sinovac’s vaccine dropped sharply six months after completion of a two-dose regimen, according to new data.   Approved or authorized vaccines

New, six-month Pfizer/BioNTech vaccine…

The state of the fight: 

Gavi inked a 550-million-dose supply deal with China’s CNBG and Sinovac.
  Bharat Biotech applied for WHO Emergency Use Listing of its inactivated vaccine.
  Cuba authorized BioFarmaCuba’s Abdala vaccine.

 

Approved or authorized vaccines

The U.S. FDA granted Priority Review to Pfizer/BioNTech’s Comirnaty vaccine in the companies’ bid for full licensure, the companies announced Friday.
 
While the press release noted a…

The University of Oxford announced Monday that its Jenner Institute has launched a Phase 1 trial in Britain of its HIVconsvX novel “mosaic” vaccine candidate that targets a broad range of HIV-1 variants.

The trial—which will test a single dose of the T cell-inducing candidate followed by a booster at four weeks in HIV-negative adults considered not to be at high risk of infection—is the first in a series of evaluations of HIVconsvX as a “vaccine strategy in both HIV-negative…

The state of the hunt:

J&J’s vaccine became the first single-dose Covid-19 jab to receive EUL from the World Health Organization.
  A growing list of countries—including at least one COVAX AMC participant—suspended their rollouts of AstraZeneca’s vaccine over safety concerns.
  Monoclonal antibodies from Lilly and a separate mAb from GSK and Vir substantially cut the risk of hospitalization or death in people with mild or moderate Covid-19 at high risk of progression…

The state of the hunt:

J&J’s single-dose vaccine scored unanimous endorsement from a U.S. FDA advisory committee, clearing the way for a likely EUA.
  The COVAX Facility made its first shipments, sending vaccine doses to Ghana and Ivory Coast.
  Moderna and Pfizer made progress toward clinical trials of modified, variant-specific vaccines.

 

Vaccines


Approved or authorized vaccines
  
Pfizer/BioNTech shot continues strong showing…

The IMPAACT4TB consortium announced Wednesday that it will roll out a new, patient-friendly preventive tuberculosis therapy in five high-burden countries, beginning in February.

Led by African NGO the Aurum Institute (with funding from Unitaid), the program will provide a fixed-dose combination of “3HP”—a short-course TB treatment combining rifapentine and isoniazid—to Ethiopia, Ghana, Kenya, Mozambique and Zimbabwe. An agreement between manufacturer Macleods, Unitaid and the Clinton…