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EU won’t renew J&J, AstraZeneca vaccine contracts, report says

[Photo by Daniel Schludi on Unsplash]

Reports from Italy claim that the European Union Commission won’t renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson.

According to Reuters, Italian outlet La Stampa reported that sources from the Italian health ministry have said the commission does not want to pursue contract renewals with those two companies once those encompassing the current year expire, with Brussels reportedly emphasizing its focus on mRNA vaccines like those produced by Pfizer/BioNTech and Moderna.

The report quoted an EU Commission spokesperson as saying the commission is keeping all options open to prepare for the next stages of the pandemic, but it can’t comment on contractual matters.

Later on today, the EU Commission president stated that the EU was in talks with Pfizer and BioNTech over a new contract for 1.8 billion doses as well, …

Pfizer asks FDA to authorize its COVID-19 vaccine for younger teens

Pfizer (NYSE:PFE) and its German partner BioNTech (NSDQ:BNTX) have asked FDA to extend the authorization of their COVID-19 vaccine to the ages of 12 to 15.

FDA authorized the vaccine for people 16 and older on Dec. 11, 2020.

The agency will likely extend its prior authorization to younger adolescents “if the data submitted support it,” according to Dr. Arnold Monto, acting chair of the Vaccines and Related Biological Products Advisory Committee meetings related to the Pfizer-BioNTech.

Pfizer plans to seek permission from other regulatory agencies to administer the vaccine to children 12 and over in the coming weeks.

The company currently has a Phase 3 trial underway involving 2,260 adolescents 12 to 15. The vaccine was 100% effective in that study, besting the results of a separate trial involving volunteers aged 16 to 25.

All 50 states plan to open up vaccine eligibility to those over 16 starting April 19.

Pfizer and BioNTech a…

NIH launches study of allergic reactions to COVID-19 vaccines

(Image by Sam Moqadam on Unsplash)

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 public began. Still, such anaphylactic reactions are rare, with only a few cases per million doses. To put things in perspective, tens of thousands of Americans end up in emergency rooms annually with severe allergic reactions.

The NIH’s National Institute of Allergy and Infectious Diseases is sponsoring and funding the news study, which is enrolling 3,400 adults ages 18 to 69 years at up to 35 academic allergy-research centers nationwide.

Get the full story on our sister site Drug Discovery & Development.

NIH launches study of allergic reactions to COVID-19 vaccines

[Image by Sam Moqadam on Unsplash]

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 public began. Still, such anaphylactic reactions are rare, with only a few cases per million doses. To put things in perspective, tens of thousands of Americans end up in emergency rooms annually with severe allergic reactions.

Most of the rare, severe allergic reactions to the vaccines took place among people with a history of allergies — many of them with prior experience of having a life-threatening allergic reaction called anaphylaxis. Researchers are still uncertain why there are rare cases of anaphylactic reactions after the Mode…

Johnson & Johnson to test COVID-19 vaccine in adolescents

Mass-vaccination efforts are ramping up, and prominent COVID-19 vaccine developers are working to lower the eligibility age for their products. Johnson & Johnson (NYSE:JNJ), for instance, has begun vaccinating adolescents in a Phase 2a clinical trial for its COVID-19 vaccine candidate.

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) recently announced that their vaccine was 100% effective in a study involving 12-to-15 year-olds. FDA has already authorized its vaccine for patients 16 or older.

Moderna (NSDQ:MRNA) announced plans to launch a Phase 2/3 study known as TeenCove that will test its COVID-19 vaccine in adolescents aged 12 to 18.

Johnson & Johnson’s recent announcement shared its plans to extend its randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) to adolescents.

The study had previously intended to evaluate the reactogenicity and immunogenicity of its Ad26.COV2.S vaccine after administering it in a vari…

Pfizer-BioNTech COVID-19 vaccine 91.3% effective after six months

The first COVID-19 vaccine to win emergency use authorization in the U.S. is highly effective for at least six months after the second dose. Developed jointly by Pfizer (NYSE: PFE) and BioNTech (NSDQ: BNTX), the BNT162b2 vaccine

The durability of COVID-19 vaccines had been something of an open question, although early clinical data suggested that Moderna’s mRNA-1273 COVID-19 vaccine was effective for at least 90 days after the second dose.

Get the full story from our sister site, Drug Discovery & Development.

Pfizer-BioNTech COVID-19 vaccine 91.3% effective after six months

The first COVID-19 vaccine to win emergency use authorization in the U.S. is highly effective for at least six months after the second dose. Developed jointly by Pfizer (NYSE: PFE) and BioNTech (NSDQ: BNTX), the BNT162b2 vaccine

The durability of COVID-19 vaccines had been something of an open question, although early clinical data suggested that Moderna’s mRNA-1273 COVID-19 vaccine was effective for at least 90 days after the second dose.

Pfizer plans on releasing more data related to the long-term vaccine immunogenicity in the coming weeks.

Pfizer and BioNTech plan on doing two years of follow-up for their Phase 3 vaccine trial.

Earlier this year, the two companies released data indicating that their vaccine also remains effective against a highly-transmissible SARS-CoV-2 variant first identified in South Africa.

Pfizer and BioNTech are also testing the vaccine on adolescents. Recent data suggest that the vaccine is 100% effective in ad…

Pfizer, BioNTech report COVID-19 vaccine works well among adolescents

Image courtesy of Wikipedia

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 was well-tolerated among the 2,260 adolescents participating in the Phase 3 trial, according to a news release.

Get the full story at our sister site, Drug Discovery & Development.

Pfizer, BioNTech report COVID-19 vaccine works well among adolescents

Image courtesy of Wikipedia

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 was well-tolerated among the 2,260 adolescents participating in the Phase 3 trial, according to a news release.

The trial observed 18 cases of COVID-19 in the placebo group (1,129 patients) compared to zero in the vaccinated group (1,131 patients). The vaccine elicited neutralizing antibody geometric mean titers (GMTs) of 1,239.5 at one month after the second dose. Participants between 16 to 25 in earlier analysis produced GMTs of 705.1, demonstrating the effectiveness among adolescents.…

Pfizer and Moderna COVID-19 vaccines 90% effective in real-world study

[Photo by Daniel Schludi on Unsplash]

A single dose of Pfizer or Moderna vaccine is about 80% effective at preventing COVID-19 infection at least two weeks after injection. The efficacy level rises to 90% two weeks after the second dose of either mRNA vaccine, according to a recent CDC study involving roughly 4,000 essential workers.

In contrast to the Phase 3 trials from Pfizer-BioNTech and Moderna, the CDC study analyzed vaccines’ ability to prevent COVID-19 infection. Study participants underwent weekly COVID-19 testing for 13 consecutive weeks.

Conversely, the Pfizer-BioNTech and Moderna Phase 3 trials sought to analyze their vaccines’ ability to prevent symptomatic COVID-19 disease. Participants in the Pfizer had to have at least one COVID-19 symptom before they received a SARS-CoV-2 test. Study volunteers in the Moderna trial had to have at least two systemic symptoms or one respiratory symptom …

EU allows Pfizer/BioNTech COVID-19 vaccine to be stored at higher temperatures

Image courtesy of Wikipedia

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, with preferred storage set in an ultra-low temperature freezer between -80ºC to -60ºC.

Get the full story at our sister site, Pharmaceutical Processing World.

EU allows Pfizer/BioNTech COVID-19 vaccine to be stored at higher temperatures

Image courtesy of Wikipedia

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, with preferred storage set in an ultra-low temperature freezer between -80ºC to -60ºC.

Get the full story at our sister site, Pharmaceutical Processing World.