CEPI

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:

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…

The Coalition for Epidemic Preparedness Innovations (CEPI) released a $3.5 billion investment case on Wednesday, outlining a five-year plan that includes a “moonshot” objective: compressing vaccine development timelines to 100 days.

Among the plan’s other goals are developing vaccines for known threats (such as chikungunya, Lassa fever and Nipah), producing a “library of prototype vaccines” from critical viral families, and supporting vaccine manufacturing in low- and middle-income…

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…

Inovio announced Tuesday that it has dosed the first participant in a West Africa-based Phase 1b trial of its INO-4500 DNA vaccine against Lassa fever.

The Pennsylvania-based company said it hopes to make the shot available for emergency use “as [a] stockpile product following Phase 2.” The candidate—delivered through Inovio’s Cellectra “smart device”—generated robust antibody and T cell immune responses in previous U.S.-based Phase 1 trials, the press release noted.

The…

Mentions:

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:

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/Oxford’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 Coalition for Epidemic Preparedness Innovations (CEPI) has launched a $26 million West African Lassa fever research program, a coalition press release said last week.

Up to 23,000 participants across outbreak-prone Benin, Guinea, Liberia, Nigeria and Sierra Leone will take part over the next 24 months in “Enable”—the largest Lassa fever research program in the region to date, according to CEPI.

Findings from Enable will guide decisions on the design of future late-stage…