Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines. The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants…

COVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg. The company and its partner BioNTech (Nasdaq: BNTX) are also developing an omicron-specific version of the vaccine. Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose…

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have launched a clinical trial to test an omicron-specific version of their COVID-19 vaccine. The two companies initially vowed to launch the updated vaccine by the end of March, but that goal may shift depending on the volume of clinical data regulators demand, according to BioNTech. In…

FDA may wait several months before deciding to authorize a COVID-19 vaccine for children between the ages of 6 months to 4 years. The agency had planned on adjourning a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the potential use of the vaccine in younger children.…

An NIH authored preprint concluded that an omicron-specific version of Moderna’s (NSDQ:MRNA) vaccine might not offer improved immunity or protection compared to the company’s current mRNA-1273 vaccine. In a small study involving macaques, NIH researchers tested neutralizing antibody levels and B cell expansion in primates receiving mRNA-1273 and mRNA-1273.529, the updated vaccine.  The study involved a total…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have begun a rolling submission for the BNT162b2 vaccine for children ages 6 months to 4 years. The FDA requested that Pfizer apply for emergency authorization for that age group, according to media reports. The agency is awaiting data from a third dose of the vaccine in the age group,…

With COVID-19 cases continuing to hover near record levels, Pfizer (NYSE:PFE) and partner BioNTech SE (NSDQ:BNTX) have launched a clinical trial to test an omicron-based vaccine candidate in adults ages 18 to 55. The study will enroll 1,420 participants divided into three cohorts. The first cohort will have already received two doses of the initial…

BioNTech (NSDQ:BNTX) and the enterprise AI company InstaDeep have announced that they have created an early warning system to improve the monitoring of potentially dangerous SARS-CoV-2 variants. The companies claim that the system spotted more than 90% of WHO-designated variants an average of two months before the organization officially classified them. For example, the system…

When confronting an onslaught of new SARS-CoV-2 variants, COVID-19 vaccine makers such as Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have tested tweaked versions of their vaccines but ultimately decided that they were unnecessary. Signs are growing that vaccines developed based on the original strain of the novel coronavirus will struggle to offer durable protection against the omicron…

Pfizer (NYSE:PFE) aims to have an omicron-specific version of its vaccine available by March. However, it still isn’t sure if the tweaked version will be necessary, said CEO Dr. Albert Bourla in an interview with CNBC’s Squawk Box. The “new version” of its COVID-19 vaccine, which it developed jointly with BioNTech (NSDQ:BNTX), should hopefully offer better…

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where…

Pfizer Inc. (NYSE:PFE) and mRNA vaccine specialist BioNTech SE (NSDQ:BNTX) will collaborate to develop an mRNA-based vaccine to prevent the herpes zoster virus (shingles). Roughly one million people in the U.S. get shingles each year, according to the CDC. Currently, the two-dose Shingrix shingles vaccine from GSK (NYSE:GSK) is the only such product available in the U.S. market.…

Soon after the omicron emerged, notable companies such as Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced efforts to develop a booster specific to the variant.   But several pharmaceutical companies are developing custom versions of COVID-19 vaccines for the variant or testing the efficacy of existing vaccines against omicron.  In October, the Moscow-based…

Moderna (NSDQ:MRNA) is touting preliminary data suggesting that its COVID-19 vaccine booster led to robust antibody increases against the Omicron variant, both at the 50 µg and 100 µg dose levels. The 50 µg booster dose, which is currently authorized under emergency use authorization, led to a 37-fold increase compared to pre-boost levels 29 days…

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have found that two 3-µg doses of their BNT162b2 (Comirnaty) vaccine were safe but generated an underwhelming immune response in children aged two to five years old. PFE shares fell 2.45% to $59.75 in early afternoon trading. The news could delay vaccine availability for younger children. As a…

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…

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…

The Advisory Committee on Immunization Practices (ACIP) at the CDC voted unanimously to allow all fully vaccinated adults to receive a COVID-19 booster at least six months after receiving a primary series. All 11 members of the panel also voted on Nov. 19 to recommend boosters for adults 50 and older. Last week, FDA authorized…

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…

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.…

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…

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…

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…

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…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. bought 50 million more doses of its COVID-19 vaccine. The U.S. purchased the additional doses of the vaccine in its effort to support preparedness for pediatric vaccinations as it seeks authorization for use in younger adolescents and children. Earlier this month, Pfizer submitted a request…