The NIH today announced that a clinical trial is underway to study whether people who are highly allergic or have a mast cell disorder are more likely to develop an allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines. Reports of severe allergic reactions to COVID-19 vaccines have made headlines since the rollout to the […]
Pfizer
Pfizer-BioNTech COVID-19 vaccine 91.3% effective after six months
The first COVID-19 vaccine to win emergency use authorization in the U.S. is highly effective for at least six months after the second dose. Developed jointly by Pfizer (NYSE: PFE) and BioNTech (NSDQ: BNTX), the BNT162b2 vaccine The durability of COVID-19 vaccines had been something of an open question, although early clinical data suggested that Moderna’s mRNA-1273 […]
Pfizer, BioNTech report COVID-19 vaccine works well among adolescents
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that their COVID-19 vaccine produced 100% efficacy among adolescents. In adolescents aged 12 to 15 years old with or without prior evidence of SARS-CoV-2 infection, the BNT162b2 vaccine demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants between 16 and 25. The vaccine […]
EU allows Pfizer/BioNTech COVID-19 vaccine to be stored at higher temperatures
Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature. Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures, […]
Early Pfizer COVID-19 vaccine doses may have had potency problems
Some of the first commercially available doses of Pfizer-BioNTech COVID-19 vaccine had lower levels of intact mRNA than anticipated, according to leaked documents reviewed by BMJ. The documents in question relate to a December breach of the European Medicines Agency (EMA), which was one of the many victims of pharma-related cyber breaches in 2020. A Pfizer […]
Pfizer launches trial for novel oral COVID-19 therapeutic
An experimental oral antiviral from Pfizer will be the focus of a Phase 1 study involving healthy adults. Known as PF-07321332, the drug has shown promise during in vitro studies against SARS-CoV-2. PF-07321332 belongs to a class of drugs known as protease inhibitors, which are commonly used to treat HIV/AIDS and hepatitis C. Protease inhibitors bind to […]
MedTech 100 roundup: Small dip keeps industry down
The last month brought a bit of a skid for the medtech industry and after a slight rebound last week, the downward trend has returned. A strong start to 2021 came to an end in late February and carried over into March, with MassDevice‘s MedTech 100 index hitting its lowest point on March 8 (102.16). It […]
Pfizer exec reportedly says COVID-19 vaccine pricing is a ‘signficant opportunity’ post-pandemic
Pfizer CFO & EVP of supply chain Frank D’Amelio has said there could be an opportunity to potentially hike up prices on its COVID-19 vaccine in a post-pandemic state. Speaking last week at the Barclays Global Healthcare Conference, D’Amelio revealed that the company is considering what will become of the vaccine situation, especially involving pricing, […]
Novax could have one of the most-effective COVID-19 vaccines
Novavax (Gaithersburg, Md.) may not be the best-known vaccine developer, but its COVID-19 vaccine offers performance in line with those from Moderna and Pfizer. Its vaccine was 96.4% effective at preventing COVID-19 caused by the original strain of the virus in a Phase 3 study. The Moderna and Pfizer vaccines offered efficacy in the mid-90% […]
Pfizer-BioNTech vaccine dramatically reduces death risk from COVID-19, study finds
Recent real-world data from the Israel Ministry of Health found that unvaccinated individuals were 29 times more likely to die due to COVID-19 complications than those who received two doses of the BNT162b2 Pfizer-BioNTech vaccine. Also, those who were unvaccinated were 44 times more likely to contract symptomatic COVID-19. The data also suggest that the […]
Why emergency authorization of COVID-19 therapies could pose regulatory questions
Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications. “I’m nervous about the prospect of there never being a COVID vaccine that meets the […]
