Pfizer

The state of the hunt:

Pfizer/BioNTech asked the U.S. FDA to expand its authorization of their vaccine to adolescents.
  Numerous countries restricted the use of the AstraZeneca/Oxford shot to older people—or discontinued it altogether—even as regulators concluded the benefits outweighed the risks.
  COVAX affirmed that SII’s supply commitments to the initiative remain “legally binding” amid continued export restrictions from India.

 

Vaccines


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 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…

Chinese CDMO WuXi Biologics announced last week that it has bought Pfizer’s GMP biologics plant in Hangzhou. WuXi expects production at the facility—which houses two 2,000-liter single-use bioreactors and fill-finish capabilities—to begin shortly after the deal closes in the first half of the year. WuXi did not disclose financial terms for the transaction. Pfizer invested $350 million in the plant in 2016 in hopes of entering the local biosimilars market.

Meanwhile, WuXi announced in…

Mentions:

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).…

The Clinton Health Access Initiative (CHAI) and the American Cancer Society (ACS) announced Monday that Biocon Biologics will join their Cancer Access Partnership (CAP), which aims to increase access to cancer treatments in low- and middle-income countries in Africa and Asia.

The addition of the Bangalore-based company—“India’s largest biopharma,” according to Biocon’s website—and an expanded portfolio of biosimilars from Pfizer will allow the partnership to offer affordable…

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…

Twelve leading pharma companies released fourth-quarter and full-year 2020 financial results in February. (Figures exclude exchange rate and portfolio changes where applicable.)

Leading the round, Gilead’s fourth-quarter revenue soared 26% over last year to $7.4 billion, beating consensus estimates by 4%. Veklury (remdesivir) drove the surge with $1.9 billion in quarterly sales: the antiviral now treats one in two hospitalized Covid-19 patients in the United States, according to the…