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 […]
Pfizer
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 […]
Is there a link between Bell’s palsy and COVID-19 vaccines?
One adverse event common to clinical trials for currently authorized COVID-19 vaccines is Bell’s palsy, an asymmetrical weakness or paralysis of the face that is often temporary. Two vaccine recipients in the Johnson & Johnson Phase 3 clinical trial developed Bell’s palsy, as did two people in the placebo group. Another patient developed facial swelling […]
Pfizer wins FDA nod to store COVID vaccine at normal freezer temps
The FDA announced today that it is allowing undiluted, frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored for up to two weeks at conventional temperatures commonly found in pharmaceutical freezers. The decision should allow for wider distribution of the vaccine to sites that do not have ultra-low temperature freezers. Get the […]