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 […]
Moderna
BioNTech and Moderna set their sights on treating cancer
COVID-19 vaccines launched BioNTech and Moderna into the limelight, making these once little-known companies prominent companies. But neither wants to be pigeonholed as a COVID-19 vaccine company. BioNTech cofounder Özlem Türeci stressed in a recent interview with AP that the mRNA vaccine technology that is its focus could be a powerful weapon against cancer. “We have several different […]
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% […]
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 […]
Baxter to make Moderna COVID-19 vaccine in US
Baxter announced that its Baxter BioPharma Solutions business will make Moderna‘s COVID-19 vaccine at its fill/finish sterile manufacturing facilities in Bloomington, Ind. The plan — announced yesterday — is for Baxter to make 60–90 million doses of the Moderna vaccine in 2021. “We have seen a remarkable demonstration of scientific and health care expertise in […]
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 […]
FDA issues guidelines to address COVID-19 variants
The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19. Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing […]
MedTech 100 roundup: Rise to new heights continues
The medtech industry hit another high as 2021 continues to bring strong performances out of some of the biggest companies around. MassDevice‘s MedTech 100 index ended the week (Feb. 12) at 110.63 points, marking a 2.2% rise from the 108.23-point mark set at the end of the previous week (Feb. 5). The final mark for the […]
Feds order 200M more vaccine doses from Pfizer, Moderna
U.S. government agencies announced that they purchased a total of 200 million additional doses of COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA). The orders of 100 million doses from each of the only two FDA-authorized vaccines in the U.S. were made by the U.S. Health & Human Services Dept. (HHS) and the Defense Dept. (DoD). The […]
Which companies will likely produce the most COVID-19 vaccine in 2021?
Since the beginning of the pandemic, much of society has pinned its hopes on the availability of a vaccine. Now that several are available across the world, there is hope, said Dr. Anthony Fauci, chief medical advisor to President Joe Biden, in a recent JAMA interview. “There’s light at the end of the tunnel.” One thing that […]
BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants
Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants. The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination. But it proved less effective in South Africa, where a new variant of […]