NIAID

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 U.S. National Institute of Allergy and Infectious Diseases (NIAID) announced on Thursday that it has awarded a total of $2.5 million in grants to 12 institutes to support research on bacteriophage therapy as a potential strategy to combat antibacterial resistance.

In other AMR news, New York-based ContraFect announced Thursday an award from the U.S. Biomedical Advanced Research and Development Authority of $9.8 million upfront and up to $77 million in milestones to fund Phase 3…

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 Journal of Clinical Investigation Tuesday published positive Phase 1 results from a U.S. National Institute of Allergy and Infectious Diseases trial showing that Maryland-based Emergent BioSolutions’ single-dose intranasal, recombinant, replicating adenovirus influenza vaccine (Ad4-H5-VTN) was safe and produced a durable immune response.

Participants who received the investigational vaccine intranasally or via tonsillar swab had significantly higher H5-specific neutralizing…

Gilead and California-based biotech Gritstone Oncology announced Monday a $60 million collaboration, option and license agreement to develop a vaccine-based immunotherapy for HIV that uses Gritstone’s proprietary self-amplifying mRNA and adenoviral vector-based vaccine platform.

Gritstone will receive $30 million in cash and $30 million in an equity investment from Gilead, along with up to $725 million in milestone payments and royalties on net sales of the drug. Gilead will conduct…

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…

The state of the hunt:

The AstraZeneca/Oxford vaccine secured its first authorizations.
  Novavax launched a 30,000-participant North American Phase 3 trial for its recombinant vaccine.
  CNBG claimed 79% efficacy for the inactivated jab from its Beijing subsidiary but provided scant data.

 

Vaccines


Approved or authorized vaccines
 
UK authorizes AstraZeneca/Oxford jab: Britain’s Medicines and Healthcare products Regulatory Agency…

The state of the hunt:

The United Kingdom issued emergency authorization of Pfizer/BioNTech’s vaccine.
  WHO is reviewing the Pfizer/BioNTech shot for Emergency Use Listing.
  Moderna requested emergency nods for its mRNA-based vaccine from the U.S. FDA and the European Medicines Agency.

 

Vaccines


Approved or authorized vaccines

Pfizer is now seeking full British marketing authorization for its Covid-19 vaccine “in parallel” with the…