Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have received emergency use authorization for BNT162b2 mRNA COVID-19 vaccine for individuals at least 16 years old. To coincide with the announcement, CDC Director Dr. Rochelle Walensky recommended that everyone 16 and older receive a booster. “Although we don’t have all the answers on the Omicron…
Three doses of Pfizer-BioNTech vaccine neutralized Omicron variant in the lab
Pfizer (NYSE:PFE) and BioNTech SE (NSDQ:BNTX) have announced that their vaccine remains effective against the Omicron variant (B.1.1.529 lineage) of SARS-CoV-2 in early lab studies. Two doses of the vaccine significantly reduced neutralization titers, while three neutralized the variant. The lab studies showed that three doses of the BNT162b2 vaccine were similar in efficacy against Omicron as two…
GSK and Vir upbeat about efficacy of sotrovimab against Omicron
GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have announced that their COVID-19 drug sotrovimab continues to offer protection against the mutations in the spike protein of the Omicron SARS-CoV-2 variant. In March, the two companies received emergency use authorization (EUA) for the drug. The EUA specifically covers the treatment of mild-to-moderate COVID-19 in high-risk adults…
FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron
Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy. In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests,…
Why Public Citizen is skeptical about the COVID-19 antiviral molnupiravir
Dr. Michael Carome, director of Public Citizen’s health research group, is concerned about Merck’s SARS-CoV-2 antiviral molnupiravir. If it wins emergency use authorization (EUA), molnupiravir would be the first oral treatment for COVID-19. But Carome brought up several potential problems with molnupiravir during today’s public comment period of the FDA’s Antimicrobial Drugs Advisory Committee meeting.…
Early data suggest COVID-19 monoclonal antibodies offer less protection against Omicron variant
The antibody cocktails from Regeneron (NSDQ:REGN) and Eli Lilly (NYSE:LLY) may provide less protection against the Omicron COVID-19 variant than earlier circulating variants. Independent researchers at the Fred Hutchinson Cancer Research Center (Seattle) concluded that bamlanivimab and etesevimab had a decrease in protection against Omicron, according to The Wall Street Journal. Omicron could be more resistant…
FDA advisory panel to weigh in on molnupiravir
An FDA advisory panel will consider whether emergency use authorization for Merck’s (NYSE:MRK) molnupiravir is warranted. The drug would be the first oral antiviral for COVID-19. Although the conclusions of the Antimicrobial Drugs Advisory Committee are not binding, FDA generally follows its recommendations. The benefit-risk calculation for molnupiravir has grown more complicated recently. Over the…
Pfizer and Moderna keeping a close watch on Omicron COVID-19 variant
Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines. The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. “I…
Senator Markey pushes U.S. to develop universal COVID-19 vaccine
Senator Edward J. Markey (D-Mass.) has sent a letter to the National Institute of Allergy and Infectious Disease (NIAID) asking for a status update regarding ongoing research to develop a universal COVID-19 vaccine. NIAID had awarded $36.3 million to academic institutions to working on coronavirus vaccines that potentially protect against multiple types of coronaviruses. Coronavirus…
Pfizer-BioNTech COVID-19 vaccine 100% effective in adolescents 12 to 15
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) shared new data from their Phase 3 study of the Comirnaty vaccine, concluding that two 30-µg doses were 100% effective against COVID-19 between seven days and four months after the second dose. The safety profile of the vaccine in the study was broadly consistent with other clinical safety data. In…
How an airway-on-a-chip model can help identify promising antivirals for COVID-19
One of the first focuses of organ-chip specialist Emulate (Boston) was to reduce the need for animal testing over time. Its technology can simulate tissue-tissue interfaces within organs using human cells. But the potential of the organ chips to yield mechanistic insights for drug discovery and understanding toxicities has become more evident over time. The…
FDA authorizes Pfizer-BioNTech and Moderna boosters for all adults
FDA has authorized booster shots of the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) vaccines for everyone 18 and older. Assuming CDC backs the decision, tens of millions of American adults who received two doses of the two mRNA COVID-19 vaccines at least six months ago will be eligible for boosters. “Authorizing the use of a single…
FDA could soon authorize Pfizer-BioNTech boosters for all adults
The FDA reportedly is planning to authorize the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccine booster for all adults in the coming days. FDA could make an announcement on the subject as soon as tomorrow, according to The New York Times. CDC’s Advisory Committee on Immunization Practices (ACIP) plans on discussing the Pfizer-BioNTech booster data on November 19.…
Atea Pharmaceuticals and Roche end joint development of COVID-19 pill
Atea Pharmaceuticals (NSDQ:AVIR) has announced the termination of a joint venture with Roche involving the development of the COVID-19 antiviral AT-527. In October, the two companies revealed that the Phase 2 MOONSONG trial focusing on AT-527 did not meet its primary endpoint. Atea will retain rights to AT-527 after the strategic collaboration with Roche ends…
RedHill Biopharma makes progress in RHB-107 COVID-19 study
RedHill Biopharma Ltd. (NSDQ:RDHL) has randomized the last patient in Part A of an ongoing Phase 2/3 study focused on RHB-107 (upamostat), an investigational antiviral. The Tel Aviv–based company anticipates that RHB-107, a serine protease inhibitor, would be broadly effective against emerging SARS-CoV-2 variants. RedHill Biopharma expects top-line data for Part A of the trial,…
Pfizer and BioNTech file for FDA authorization of COVID-19 vaccine boosters for all adults
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have filed paperwork with FDA to authorize their COVID-19 vaccine for all adults 18 and older. The two companies had filed a supplemental Biologics License Application for a booster dose of the COVID-19 vaccine in adults at least 16 years old. FDA did not accept the supplemental Biologics License…
U.S. to buy 1.4 million additional courses of molnupiravir
Merck (NYSE:MRK) and Ridgeback Biotherapeutics appear to be gaining growing support for their oral COVID-19 therapy molnupiravir. One week after Great Britain granted conditional marketing authorization for the drug, the companies announced that the U.S. government intends to purchase 1.4 million additional medicine courses for approximately $1 billion. The U.S. has committed to buy approximately 3.1…
Moderna pursues EU authorization of its COVID-19 vaccine in children aged 6 to 11
Moderna (NSDQ: MRNA) has filed paperwork to permit the evaluation of two 50-µg doses of its Spikevax (mRNA-1273) vaccine in children ages 6-11 years in the European Union. Moderna has filed paperwork to permit the evaluation of its Spikevax vaccine in children ages 6–11 years in the European Union. Last week, the company announced that FDA…
Pfizer’s COVID-19 pill reduced risk of hospitalization or death by 89%
Pfizer (NYSE:PFE) today announced that its oral antiviral cut the risk of hospitalization or death by 89% in an interim analysis of the Phase 2/3 EPIC-HR trial. Until recently, there were no oral treatments against the novel coronavirus. Molnupiravir, an oral antiviral from Merck (NYSE:MRK) and Ridgeback Biotherapeutics, recently won approval in the United Kingdom…
UK approves Merck’s oral COVID-19 drug molnupiravir
The United Kingdom has become the first country to authorize molnupiravir, the oral antiviral drug from Merck (NYSE:MRK) and Ridgeback Biotherapeutics. The Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for the drug in Great Britain. Furthermore, it has allowed emergency use authorization of the drug for Northern Ireland. MHRA recommends that…
Moderna takes big hit on missed Q3 projections
Moderna (NSDQ:MRNA) shares took a big hit today on third-quarter results that came up short of the consensus forecast. MRNA shares were down 17.1% at $286.80 per share in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.2%. Get the full story at our…
CDC backs Pfizer’s COVID-19 vaccine for 5- to 11-year-olds
The Comirnaty vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) could soon be available for children between the ages of 5 and 11, now that CDC has backed its use. CDC Director Dr. Rochelle P. Walensky formally authorized the vaccine after the Advisory Committee on Immunization Practices (ACIP) unanimously recommended its use. “We know millions of parents are…
FDA delays EUA decision for Moderna vaccine in teens
Moderna (NSDQ:MRNA) saw its share price fall 5% in mid-day trading today after the FDA said it would delay authorizing its mRNA-1273 vaccine in 12- to 17-year-olds. The agency said it needed additional time to investigate the risk of myocarditis in younger vaccine recipients. FDA informed Moderna that it may not complete its review before…
FDA backs Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11
The FDA has moved to expand vaccine eligibility to include children at least 5 years old. Earlier this week, the agency’s Vaccines and Related Biological Products Advisory Committee concluded that the benefits of the Pfizer-BioNTech (NYSE:PFE/NASDAQ:BNTX) for children 5 to 11 outweigh the risks. The recommendation pertained to two 10-µg doses of the vaccine, which is one-third…
Sanofi is banking on a $10 COVID-19 vaccine
Sanofi (NSE:SANOFI) and its partner GSK (NYSE:GSK) are hoping the low price of their experimental COVID-19 vaccine will stoke interest. In a call with analysts, Thomas Triomphe, head of the Sanofi Pasteur vaccines division, said that its vaccine would cost less than $10 per dose. For the sake of comparison, Pfizer-BioNTech and Moderna COVID-19 vaccines generally cost…