FDA

The state of the fight: 

Regeneron and Roche’s REGEN-COV became the first antibody drug to score U.S. FDA clearance for post-exposure prophylaxis of Covid-19.
  Six-month data on Pfizer/BioNTech’s vaccine showed continuing high efficacy against severe disease.
  Antibody levels induced by Sinovac’s vaccine dropped sharply six months after completion of a two-dose regimen, according to new data.   Approved or authorized vaccines

New, six-month Pfizer/BioNTech vaccine…

GSK used its second-quarter 2021 results, released Wednesday, to announce the abandonment of a Phase 2 pediatric RSV vaccine candidate after results showed the shot (GSK3389245A/ChAd155-RSV) was unlikely to meet target efficacy. The company also has adult and maternal immunization candidates for RSV in Phase 3.

Nonetheless, the U.S. FDA did hand GSK a good start to the week: on Monday, the agency expanded the market for Shingrix, approving the blockbuster shot for the prevention of…

Mentions:

Merck’s next-generation 15-valent pneumococcal conjugate vaccine (PCV) earned U.S. FDA approval in adults last week, crossing the finish line for people age 18 and older nearly six weeks after rival Pfizer’s 20-valent shot.

Even so, Merck’s Vaxneuvance seems poised to beat Pfizer in the race for the lucrative pediatric market. Merck said in May that it plans to seek FDA approval for the shot’s use in children this year.

Mentions:

Sanofi announced Monday that the U.S. FDA has approved its oral sleeping sickness treatment, fexinidazole, in patients age 6 and older and weighing at least 20 kilograms. According to the press release, the approval also nets a tropical disease Priority Review Voucher for Sanofi’s co-developer, the Drugs for Neglected Diseases Initiative. Sanofi and DNDI will share the PRV benefits.

The EMA approved the drug in 2018.

The novel 24-valent pneumococcal polysaccharide vaccine (PPSV) candidate from Affinivax and Astellas has notched U.S. FDA Breakthrough Therapy designation on the strength of new Phase 2 data, the companies announced Tuesday.

The results showed that ASP3772—based on Affinivax’s proprietary Multiple Antigen Presenting System (MAPS)—was well tolerated and induced antibody responses to each of its 24 serotypes, according to the press release. The study compared the shot to two market…

Valneva announced Wednesday that the U.S. FDA has granted its VLA1553 single-shot chikungunya vaccine candidate (currently in Phase 3) Breakthrough Therapy Designation—adding to the PRIority MEdicines (PRIME) designation the EMA awarded the French company’s jab in 2020 and the FDA Fast Track status it received in 2018.

The U.S. FDA approved Pfizer’s 20-valent pneumococcal conjugate vaccine (PCV) on Tuesday, handing the company a win over rival Merck for the world’s first next-generation PCV authorization. The shot, Prevnar 20, is also under EMA review, the company’s press release said.

Merck’s 15-valent PCV candidate (V114) may win the pediatric race, however, as the multinational plans to file for a pediatric indication by the end of the year. An FDA decision on Merck’s V114 for adults is expected…

Mentions:

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:

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:

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…