UNITAID

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…

The state of the hunt:

COVAX has inked a deal for up to 40 million doses of Pfizer/BioNTech’s vaccine.
  India launched its mass vaccination campaign against Covid-19.
  China and India are both giving away vaccine doses to their neighbors.

 

Vaccines


Approved or authorized vaccines
 
China’s Sinovac jab more effective using three-week interval: A silver lining has emerged to last week’s middling news from the Butantan Institute’s…

Newly formed generics giant Viatris announced Monday that the U.S. FDA has tentatively approved its 10mg pediatric dolutegravir antiviral tablets for oral suspension for treatment of HIV-1.

According to the press release, the tentative approval—granted under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)—permits the distribution in certain PEPFAR countries of generic products still under U.S. patent or exclusivity protection.

Pfizer’s Upjohn generics subsidiary…

The state of the hunt:

CEPI expanded its funding for Clover Biopharmaceuticals’ S-Trimer Covid-19 vaccine candidate to $328 million.
  Humanigen touted positive interim Phase 3 results for lenzilumab and announced a cooperative R&D deal with the U.S. government.
  Russia approved a domestic version of Fujifilm’s Avigan for coronavirus outpatients, dubbing the product “the first [f]avipiravir-based drug in the world approved for the treatment of COVID-19.”

 

Two different four-month treatment regimens for tuberculosis proved non-inferior to the standard six-month regimens for their trial populations, according to Phase 3 results presented separately at last week’s Union World Conference on Lung Health.

First, a 13-country, U.S. Centers for Disease Control and Prevention-led trial of over 2,500 participants with drug-susceptible TB found that an abbreviated regimen—which modified the standard treatment (a combination of isoniazid, rifampin…

Mentions:

The state of the hunt:

Vaccine candidates from Bharat Biotech, Medicago, Zydus Cadila and the University of Queensland entered Phase 1 or 1/2 trials this week.
  Inactivated candidates from CNBG entered Phase 3.
  India issued emergency approval of Biocon’s itolizumab for the treatment of coronavirus-related cytokine-release syndrome.

 

Vaccines

Clinical trials:

Moderna says 30,000-participant Phase 3 trials of its investigational mRNA vaccine…

WHO issued a detailed investment case last Friday appealing for $31.3 billion over the next 12 months—$13.7 billion of it “urgently”—to fund the three main pillars of the Access to COVID-19 Tools (ACT) Accelerator.

The ACT Accelerator’s goals include delivering 2 billion vaccine doses by the end of 2021 and supplying 245 million courses of therapeutics and 500 million tests to low- and middle-income countries by mid-2021.

The Coalition for Epidemic Preparedness Innovations, Gavi…

The state of the hunt:

China sent another inactivated candidate to Phase 2—its fourth vaccine of that type to move beyond Phase 1 trials.
  CEPI has identified manufacturing capacity for 4 billion vaccine doses.
  The WHO-led Access to COVID-19 Tools (ACT) Accelerator is seeking almost $28 billion in additional funds.

 

Vaccines

Clinical trials:

Another Chinese candidate in Phase 2: An inactivated vaccine from the Chinese Academy of Medical…