EMA

Covid-19 development round-up: March 4, 2022

The state of the fight: 

Pfizer/BioNTech’s Comirnaty appeared to offer only 12% effectiveness against Omicron in children ages 5-11.
  South Africa’s Biovac partnered with nine development institutions to boost local vaccine manufacturing capacity.
  Eli Lilly’s arthritis drug Olumiant reduced the risk of death by 13% in hospitalized Covid-19 patients.   AUTHORIZED VACCINES

 
Pfizer/BioNTech’s Comirnaty is far less protective against infection in children…

Mentions:
Covid-19, vaccines, drugs, Pfizer, BioNTech, Novavax, Sinovac, Valneva, FDA, Bharat Biotech, Inovio, Shionogi, CureVac, GSK, Biovac, Gamaleya Institute, WHO, MPP, Moderna, Bio Farma, ACT-A, EMA, J&J, AstraZeneca, Merck, Regeneron, Roche, Lilly, Gilead, DNDi
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Covid-19 development round-up: February 25, 2022

The state of the fight: 

Sanofi and GSK’s vaccine candidate demonstrated 58% efficacy against symptomatic Covid-19 in Phase 3.
  Hetero Pharma’s generic version of Merck’s molnupiravir reduced the risk of hospitalization by over 65%.
  Britain and Japan pledged a combined $514 million to CEPI’s pandemic preparedness plan.   AUTHORIZED VACCINES

 
The U.S. FDA lifted its clinical hold on Bharat Biotech’s Covaxin, clearing the way for the inactivated vaccine…

Mentions:
Covid-19, vaccines, drugs, Bharat Biotech, FDA, Ocugen, Pfizer, BioNTech, CDC, Medicago, GSK, Moderna, Gamaleya Institute, CNBG, Sinopharm, EMA, CanSino, Anhui Zhifei Longcom, Sanofi, Thermo Fisher, Valneva, CEPI, AstraZeneca, Sinovac, Africa CDC, COVAX, WHO, J&J, Vir, Merck, Gilead, Shionogi, Suzhou Abogen, Walvax
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Covid-19 development round-up: February 11, 2022

The state of the fight: 

A Lilly mAb active against Omicron won a U.S. FDA emergency use nod.
  Novavax’s shot proved 80% efficacious in adolescents ages 12-17, according to a Phase 3 readout.
  Vaxxinity’s UB-612 vaccine candidate performed better against Omicron than an mRNA-based comparator jab.

 

AUTHORIZED VACCINES

 
J&J’s single-dose shot was only 53% efficacious against moderate to severe Covid-19 (28 days post-injection) in a final…

Mentions:
Covid-19, vaccines, drugs, J&J, Novavax, FDA, Pfizer, BioNTech, Bharat Biotech, CNBG, Sinopharm, Gamaleya Institute, Sinovac, EMA, AstraZeneca, Walvax, Moderna, Biological E, African Union, COVAX, WHO, ACT-A, Lilly, Gilead, Merck, GSK, Vir, Regeneron, Roche, DNDi, Novartis
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Covid-19 development round-up: January 28, 2022

The state of the fight: 

Moderna and Pfizer/BioNTech launched trials of Omicron-specific vaccine candidates.
  India fully approved SII’s Covishield and Bharat Biotech’s Covaxin shots.
  CEPI tapped BioNet to develop a “variant-proof” pan-coronavirus mRNA-based vaccine.

AUTHORIZED VACCINES  

New data on rates of myocarditis following mRNA-based vaccination trickled in this week, highlighting an increased risk of the heart inflammation side effect in young…

Mentions:
Covid-19, vaccines, drugs, SII, BBIL, Pfizer, BioNTech, Moderna, J&J, Sinovac, CanSino, AstraZeneca, EMA, FDA, Sanofi, GSK, Novavax, Zydus Cadila, CEPI, COVAX, Gavi, MPP, Merck, Lilly, Regeneron, Roche, Gilead
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Covid-19 development round-up: January 21, 2022

The state of the fight: 

African vaccine production advanced on multiple fronts, including the opening of a new manufacturing plant in South Africa.
  The COVAX AMC seeks an additional $5.2 billion this year.
  Merck will supply UNICEF with up to 3 million courses of molnupiravir in the first half of 2022.

AUTHORIZED VACCINES  

The Chilean health ministry released data on the Sinovac jab’s effectiveness in children. In kids ages 6-11, the topline numbers…

Mentions:
Covid-19, vaccines, drugs, WHO, Pfizer, BioNTech, Sinovac, EMA, Moderna, J&J, SII, BBIL, Novavax, Gamaleya Institute, Valneva, Clover, CEPI, IPD, COVAX, Gavi, Merck, UNICEF, MPP, GSK, Vir, Gilead, Regeneron, Roche
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Covid-19 development round-up: January 14, 2022

The state of the fight: 

A booster dose of Bharat Biotech’s Covaxin increased neutralizing antibodies up to 265-fold.
  WHO added therapies from Eli Lilly and GSK/Vir to its list of recommended Covid-19 treatments.
  Novartis will pay over $162 million to in-license Molecular Partners’ ensovibep antiviral candidate.

 

AUTHORIZED VACCINES

Two doses of Pfizer/BioNTech’s vaccine reduced the risk of Covid-19 hospitalization by 94% among adolescents…

Mentions:
Covid-19, vaccines, drugs, Pfizer, BioNTech, AstraZeneca, Moderna, J&J, Janssen, FDA, EMA, BBIL, Novavax, SII, WHO, Sinovac, CanSino, COVAX, UNICEF, Lilly, GSK, Vir, Regeneron, Roche, Merck, Novartis
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Pfizer next-gen PCV scores EMA nod

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Pfizer’s 20-valent pneumococcal conjugate vaccine in adults, the company announced last week. Prevnar 20—to be marketed in Europe as Apexxnar—scored its U.S. FDA nod in June.

Pfizer remains locked in a next-gen PCV race with Merck, whose 15-valent shot crossed the regulatory finish line after Pfizer’s in the U.S. but took first place in the E.U.

Mentions:
PCV, vaccines, Pfizer, Merck, regulatory, pneumo, EMA
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Covid-19 development round-up: December 17, 2021

The state of the fight: 

WHO issued an Emergency Use Listing for Serum Institute of India’s version of Novavax’s vaccine.
  The U.S. CDC recommended mRNA-based vaccines over J&J’s.
  Data on the effectiveness of monoclonal antibody therapies against the Omicron variant began pouring in.

AUTHORIZED VACCINES  

A U.S. CDC advisory panel recommended mRNA-based vaccines over the J&J jab, citing blood clot side effects stemming from the single-…

Mentions:
Covid-19, vaccines, drugs, Moderna, NIH, J&J, Janssen, Pfizer, BioNTech, CanSino, SII, Novavax, WHO, EMA, COVAX, FDA, Takeda, Butantan Institute, Sinovac, BBIL, Sanofi, GSK, AstraZeneca, Valneva, CNBG, Sinopharm, Gamaleya Institute, Gavi, CEPI, Merck, Regeneron, Roche, Lilly, Vir, Novartis
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Covid-19 development round-up: December 9, 2021

The state of the fight: 

New studies supported heterologous primary regimens and heterologous boosters.
  Serum Institute of India is weighing slashing Covishield production by 50%.
  The U.S. FDA OK’d AstraZeneca’s Evusheld long-acting monoclonal antibody therapy as PrEP for certain groups.

 

AUTHORIZED VACCINES  

Mixing the AstraZeneca/Oxford or Pfizer/BioNTech vaccines with a second dose of Moderna’s shot generated non-inferior immune responses…

Mentions:
Covid-19, vaccines, drugs, AstraZeneca, Pfizer, BioNTech, Moderna, Novavax, Finlay Institute, Gamaleya Institute, CureVac, J&J, Janssen, Valneva, EMA, Bavarian Nordic, Sinovac, CEPI, SII, Gavi, COVAX, Africa CDC, WHO, World Bank, UNICEF, Zydus Cadila, Thermo Fisher, Merck, FDA, GSK
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Covid-19 development round-up: December 3, 2021

The state of the fight: 

A slew of vaccine manufacturers announced plans to tackle the Omicron variant.
  Aspen Pharmacare and J&J neared a deal that would let the South African manufacturer market its own version of the Janssen shot.
  Gavi’s board approved the alliance’s COVAX strategy for 2022.

AUTHORIZED VACCINES  


New research on the Pfizer/BioNTech shot affirmed its efficacy in younger people and its safety in older people.
 
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Mentions:
Covid-19, vaccines, drugs, Pfizer, BioNTech, BBIL, FDA, Moderna, Gamaleya Institute, AstraZeneca, CNBG, Sinopharm, J&J, Janssen, Sinovac, Valneva, CEPI, Finlay Institute, Inovio, Novavax, WHO, EMA, Walvax, CureVac, Gavi, COVAX, MPP, Africa CDC, Merck, Lilly, Regeneron, Roche, GSK, Vir, Pfizer
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