GSK

Sanofi CEO Paul Hudson announced on Tuesday the creation of a nonprofit unit, Sanofi Global Health, which will provide 40 lower-income countries with access to 30 of the company’s “most essential medicines,” including cardiovascular, diabetes, tuberculosis, malaria and cancer treatments.

An accompanying press release said Sanofi Global Health will be the cornerstone of the Paris-based company’s corporate social responsibility strategy for “access to medicines, support for vulnerable…

The state of the hunt:

Pfizer and BioNTech plan to seek authorization of their vaccine for adolescents age 12-15 after promising Phase 3 results.
  J&J agreed to supply up to 400 million doses of Janssen’s jab to the African Union.
  Serum Institute of India launched clinical trials of its version of the Novavax vaccine candidate.

 

Vaccines


Approved or authorized vaccines
   
New data show lower efficacy for Pfizer/BioNTech: The…

The Access to Medicine (AtM) Foundation last week published a pediatric analysis of additional results from its 2021 AtM Index, finding just 7% of pharmaceutical companies’ R&D is for children under 12, despite significant gaps in treatment options for children.

The report praised GSK, Johnson & Johnson and Sanofi for being “the most active” in developing pediatric versions of products, and also named examples of drugs that “could each make a big difference” for LMICs: Eli…

The state of the hunt:

The European Union and India made new moves to curtail vaccine exports.
  COVAX warned of delivery delays.
  Pfizer and BioNTech launched a pediatric trial of their vaccine in children as young as 6 months.

 

Vaccines


Approved or authorized vaccines
   
New data, new questions for AstraZeneca: If AstraZeneca thought higher-than-expected efficacy results this week from the U.S.-based Phase 3 trial of AZD1222 would…

GSK today fired veteran vaccines adviser Moncef Slaoui as board chair of its majority-controlled Galvani Bioelectronics over “substantiated” allegations of sexual misconduct. An investigation remains ongoing, according to the GSK press release.

Per the press release, Slaoui’s behaviors were “wholly unacceptable” and contrary to the “strong values that define GSK’s culture.”

Slaoui became well known in 2020 as chief scientist to the U.S. government’s Operation Warp Speed…

The state of the hunt:

Moderna began clinical trials of its vaccine in children.
  New vaccines from Iran and Vietnam entered human trials, and a Cuban shot reached Phase 3.
  France limited use of AstraZeneca’s vaccine to people 55 or older.

 

Vaccines


Approved or authorized vaccines
  
AZ jab is safe, EMA reaffirms—but will uptake suffer? A European Medicines Agency (EMA) risk assessment committee concluded a preliminary review…

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…

Médecins Sans Frontières (MSF), Save the Children, UNICEF and WHO issued a press release last week welcoming the addition of GSK’s rotavirus vaccine, Rotarix, to their Humanitarian Mechanism, which allows civil society organizations in countries not otherwise eligible for Gavi support to buy shots at manufacturers’ lowest available price for use in emergencies.

Founded in 2017, the Humanitarian Mechanism was previously limited to pneumococcal conjugate vaccines (from GSK and Pfizer).…

Merck, Gilead and ViiV captured headlines for their HIV portfolios at this week’s annual Conference on Retroviruses and Opportunistic Infections (CROI).

First, Merck announced on Monday that a reformulated version of its islatravir NRTTI subdermal implant for HIV-1 pre-exposure prophylaxis (PrEP) may provide protection for “at least one year,” based on Phase 1 data. A company researcher told NAM Aidsmap that planned Phase 2 trials of the new version will be “very similar” to the Phase…

Mentions:

The state of the hunt:

Serum Institute of India will export Covishield doses to the United Kingdom.
  COVAX unveiled initial vaccine allocations, and numerous COVAX participants received their first shipments and began administering jabs.
  Bharat Biotech’s Covaxin demonstrated 81% efficacy against symptomatic disease in an interim Phase 3 analysis.

 

Vaccines


Approved or authorized vaccines
  
U.S. regulators completed their signoff…