Dynavax

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…

Dynavax and Serum Institute of India (SII) announced last week the dosing of the first participant in a Phase 1 trial of their potentially more durable Tdap (tetanus, diphtheria and acellular pertussis) vaccine candidate combining SII’s antigens and the California company’s CpG 1018 adjuvant.

The press release quoted SII CEO Adar Poonawalla as saying the product would protect “children, adolescents and adults in the developed world.”

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 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:

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…

The state of the hunt:

Remdesivir showed “little or no effect” on 28-day mortality or the duration of hospital stay among hospitalized Covid-19 patients, according to data from a WHO study.
  J&J paused all dosing in trials involving its Janssen subsidiary’s vaccine candidate.
  Pfizer will not apply for U.S. FDA Emergency Use Authorization for its mRNA Covid-19 vaccine candidate before the third week of November.

 

Vaccines

Phase 3 candidates:…

The state of the hunt:

Phase 3 trials of AstraZeneca’s AZD1222 vaccine candidate resumed in Brazil, Britain, India and South Africa, while U.S. officials voiced safety concerns.
  The United Arab Emirates joined China in issuing emergency approval of a CNBG inactivated vaccine candidate.
  A trial of Lilly’s RA drug Olumiant in combination with remdesivir met its primary endpoint.

 

Vaccines

Phase 3 candidates:
 
Phase 3 trials resumed last…

The state of the hunt:

The EU is reportedly weighing abstention from the COVAX Facility due to vaccine pricing and timing concerns.
  An inhaled interferon drug produced extraordinary Phase 2 data in a study some critics have faulted.
  Vaccines from AstraZeneca-Oxford University, CanSino, and Pfizer-BioNTech had positive Phase 1/2 or Phase 2 news.

 

Vaccines

Clinical trials:

The Lancet published preliminary Phase 1/2 results Monday showing the…

California-based Dynavax and New York’s Icahn School of Medicine at Mount Sinai announced last week that they will work together on a chimeric hemagglutinin (cHA)-based universal influenza vaccine using Dynavax’s CpG 1018 adjuvant. Last year, Mount Sinai published positive Phase 1 results showing that its novel cHA approach induced a broad antibody response for currently circulating human strains as well as avian and bat flu virus subtypes.

The Collaborative Influenza Vaccine…