Catalent

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:

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…

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:

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…

The state of the hunt:

Novavax’s protein-based vaccine candidate demonstrated 89.3% efficacy in a UK Phase 3 trial.
  J&J/Janssen’s single-dose vaccine was 66% effective against moderate to severe disease in Phase 3.
  Vaccines from J&J, Moderna, Novavax and Pfizer/BioNTech appear less effective against the SARS-CoV-2 variant first identified in South Africa.

 

Vaccines


Approved or authorized vaccines

AstraZeneca’s vaccine…

The state of the hunt:

The Pfizer/BioNTech vaccine received several new authorizations, including from the European Union.
  Canada joined the U.S. in authorizing Moderna’s jab. .
  Argentina and Belarus became the first countries outside Russia to OK Sputnik V.

 

Vaccines


Approved or authorized vaccines
 
Pfizer and BioNTech will market their BNT162b2 vaccine in the European Union under the brand name Comirnaty after receiving…

The state of the hunt:

AstraZeneca commenced a U.S. Phase 3 trial of its AZD1222 vaccine candidate.
  Sanofi/GSK launched the first human trials of their investigational adjuvanted vaccine.
  Germany, Japan and Norway joined the COVAX Facility, which now has commitments from 78 upper- and upper-middle-income countries.

 

Vaccines

Phase 3 candidates:
 
AstraZeneca’s AZD1222 vaccine entered a United States-based Phase 3 trial targeting 30,000…

The state of the hunt:

Novavax brought its vaccine candidate to Phase 2.
  WHO reportedly offered wealthier countries new, more flexible terms for the COVAX Facility.
  The U.S. FDA expanded the Emergency Use Authorization for Gilead’s Veklury (remdesivir).

 

Vaccines

Phase 3 candidates:
 
Pfizer and BioNTech have enrolled more than half of the 30,000 people they seek for U.S.-based Phase 3 trials of their mRNA Covid-19 vaccine candidate,…

Several contract development and manufacturing organizations announced this month that they are expanding operations to meet growing demand.

First, New Jersey-based Catalent announced last week that it is boosting softgel production capacity at its Buenos Aires facility for “high potency treatments in areas such as oncology” by the end of 2021.

Next, South Korea’s Samsung Biologics said it is investing approximately $2 billion in what it claims will be the world’s largest single-…

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…