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COVID-19 vaccine trial

FDA advisory panel recommends boosters only for older and high-risk individuals

September 17, 2021 By Brian Buntz

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals […]

Filed Under: Featured, Pharmaceutical Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, COVID-19 vaccines, FDA, Pfizer, Vaccines and Related Biological Products Advisory Committee, VRBPAC

COVID-19 vaccine booster tensions mount between White House, CDC and FDA

September 15, 2021 By Brian Buntz

Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20.  But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary.  Two departing senior FDA vaccine officials recently co-wrote […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, CDC, Centers for Disease Control & Prevention (CDC), COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, FDA, Pfizer

Pfizer seeks FDA blessing for COVID-19 vaccine booster

August 25, 2021 By Brian Buntz

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older. The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55. The latest data indicate that […]

Filed Under: Featured, Pharmaceutical Tagged With: BioNTech, Comirnaty, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, COVID-19 vaccines

Janssen COVID-19 booster leads to nine-fold increase in neutralizing antibodies

August 25, 2021 By Brian Buntz

Johnson & Johnson (NYSE:JNJ) has announced that a booster of its viral-vector COVID-19 vaccine led to considerable increases in coronavirus spike-binding antibodies, according to interim data from two Phase 1/2 trials known as VAC31518COV1001 and VAC31518COV2001. In particular, the boosters led to a nine-fold increase in antibodies relative to levels 28 days after administering the prime […]

Filed Under: Featured, Pharmaceutical Tagged With: coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, COVID-19 vaccines, Janssen Pharmaceuticals, Johnson & Johnson, VAC31518COV1001, VAC31518COV2001

Novavax stock surges after striking EU COVID-19 vaccine deal

August 4, 2021 By Brian Buntz

Novavax (NSDQ:NVAX) saw its stock jump more than 20% in afternoon trading after the European Commission agreed to purchase up to 200 million doses of its vaccine.  The Gaithersburg, Md.–based vaccine maker announced in March that its NVX-CoV2373 vaccine was 96.4% effective against the original SARS-CoV-2 strain in a U.K. trial. The efficacy in a later trial […]

Filed Under: Featured, Pharmaceutical Tagged With: AstraZeneca plc, BioNTech, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, COVID-19 vaccines, Moderna, Novavax, Novavax Inc., NVX-CoV2373, Pfizer

FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents

May 10, 2021 By Brian Buntz

The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020. The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic […]

Filed Under: Featured, Pharmaceutical Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, FDA, Moderna, Pfizer

Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2

May 5, 2021 By Sean Whooley

Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine. Speaking during the company’s first-quarter earnings call yesterday, transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is […]

Filed Under: Featured, Food & Drug Administration (FDA), Pediatrics, Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, COVID-19 variants, FDA, Pfizer

NIH launches study of allergic reactions to COVID-19 vaccines

April 7, 2021 By Chris Newmarker

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 […]

Filed Under: Clinical Trials, Featured, Pharmaceutical Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine trial, Moderna, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Pfizer

NIAID expresses concern over AstraZeneca’s COVID-19 vaccine data

March 23, 2021 By Sean Whooley

The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial. NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned that information the company released from its AZD1222 vaccine clinical trial may be outdated. In turn, that […]

Filed Under: Clinical Trials, Featured, Pharmaceutical, Regulatory/Compliance Tagged With: AstraZeneca, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

AstraZeneca touts COVID-19 vaccine study results, will seek FDA nod

March 22, 2021 By Sean Whooley

AstraZeneca announced today that its COVID-19 vaccine demonstrated statistically significant efficacy in preventing COVID-19 in a U.S. trial. AZD1222, developed in a collaboration between London-based AstraZeneca and Oxford University, was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization, according to a news release. Efficacy was consistent across ethnicity […]

Filed Under: Clinical Trials, Featured, Pharmaceutical Tagged With: AstraZeneca, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, Oxford University

FDA analysis finds J&J’s single-done COVID-19 vaccine is safe, effective

February 24, 2021 By Sean Whooley

An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, FDA, Janssen Pharmaceuticals, Johnson & Johnson

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