EuBiologics

The state of the fight: 

Oral antivirals from Pfizer and Merck notched U.S. FDA authorizations.
  Earlier use of remdesivir cut the risk of death or hospitalization by 87% in a new study.
  The Novavax vaccine secured a second WHO Emergency Use Listing.

AUTHORIZED VACCINES  

The AstraZeneca/Oxford vaccine starts waning in protection against serious illness within three months of the second dose, according to cohort studies in Brazil and Scotland published…

The state of the fight: 

More European countries cautioned against Moderna’s vaccine for younger people over concerns about side effects.
  Generics companies are preparing to roll out their versions of Merck’s molnupiravir oral antiviral.
  Pfizer is in talks with 90 countries over supply deals for its antiviral candidate.

 

AUTHORIZED VACCINES  


France and Germany recommended against the Moderna vaccine for people under 30 over concerns about…

Local media reported Monday that Mumbai-based TechInvention has struck an import deal with EuBiologics to market the South Korean company’s oral cholera vaccine (OCV) in India.

Business Standard quoted TechInvention CEO Syed Ahmed as saying the move fills a market gap resulting from Sanofi’s OCV production pause at its Shantha subsidiary. TechInvention is targeting a price range for Euvichol-Plus of $8-$10 per single dose in India’s private market, according to the article. The company…

The state of the hunt: 

China authorized Sinovac’s vaccine for children as young as age 3.
  The U.S. will reportedly divert $2 billion from COVAX to pay Pfizer/BioNTech for doses it intends to donate.
  Merck entered a $1.2 billion deal to supply an investigational antiviral to the U.S., pending a regulatory nod.   Approved or authorized vaccines

China cleared Sinovac’s CoronaVac jab for youths ages 3 to 17, becoming the first country to offer Covid-19 vaccines to…

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:

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:

Pfizer/BioNTech’s vaccine won U.S. FDA Emergency Use Authorization.
  The inactivated vaccine from CNBG’s Beijing subsidiary secured UAE registration.
  Bharat Biotech and SII requested Indian authorization of their respective jabs.

 

Vaccines


Approved or authorized vaccines
 
The Pfizer/BioNTech vaccine extended its regulatory lead this week with new authorizations, including a U.S. nod.
 
The U.S.…

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:

Moderna’s and Pfizer/BioNTech’s vaccines entered 30,000-participant late-stage trials in the United States.
  Britain and the United States entered supply deals for at least 160 million doses of the GSK/Sanofi vaccine candidate.
  Gavi identified 92 LMICs eligible for its COVAX Advance Market Commitment.

 

Vaccines

Clinical trials:

Moderna reaches Phase 3: The Massachusetts-based company has begun dosing in a study of its…