BioNTech Archives - Page 17 of 20 - Medical Design Sourcing

What are the most common COVID-19 vaccine side effects?

[Photo by Daniel Schludi on Unsplash]

Now that it has been nearly four months since the FDA authorized the first COVID-19 vaccine, a decent amount of safety information is available about the Pfizer-BioNTech vaccine.

CDC recently released a summary of adverse event data related to the Pfizer-BioNTech vaccine based on more than 5,000 entries to the Vaccine Adverse Event Reporting System collected from Dec. 14, 2020, to Jan. 13.

The summary also included data related to more than 1,000 recipients of the first dose of Moderna COVID-19 vaccine.

The entries make up only a minuscule fraction of the more than 90 million doses of COVID-19 vaccine that Americans have received to date.

A total of 93.7% of the reports related to the first dose of Pfizer-BioNTech vaccine were nonserious, although that figure dropped to 78.6% when it came to the second dose. For the Moderna vaccine, 81.2% of the event…

Pfizer wins FDA nod to store COVID vaccine at normal freezer temps

Pfizer-BioNTech vaccine (Image courtesy of Wikipedia)

The FDA announced today that it is allowing undiluted, frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored for up to two weeks at conventional temperatures commonly found in pharmaceutical freezers.

The decision should allow for wider distribution of the vaccine to sites that do not have ultra-low temperature freezers.

Get the full story on our sister site, Medical Design & Outsourcing.

Could a third vaccine shot better protect against COVID-19 variants?

[Photo by Daniel Schludi on Unsplash]

Pfizer/BioNTech and Moderna are testing whether a third dose of their COVID-19 vaccines could better protect against new virus variants.

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that participants from their Phase 1 study will be offered the opportunity to receive a 30 µg booster of the current vaccine 6 to 12 months after receiving their initial two doses. The two companies are also in discussions with regulatory authorities including the U.S. FDA and European Medicines Agency about a registration-enabled clinical study of a vaccine with a modified mRNA sequence geared toward the South African variant.

“While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by t…

Is J&J’s COVID-19 vaccine linked to tinnitus?

In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears.

In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer.

No placebo recipients developed the condition.

J&J concluded that the tinnitus reports were likely unrelated to the vaccine. The principal investigator in the trial that two of the events were related and the remainder unrelated.

A 21-year-old volunteer involved in an earlier clinical trial for the J&J vaccine developed tinnitus and sudden hearing loss 34 days after receiving the vaccine. The patient recovered 69 days after receiving the injection. Johnson & Johnson also determined that the event was unrelated to the vaccine.

In all, some 43,783 volunteers participated in the Phase 3 trial. A total of 19,630 participants received the Ad26.COV…

FDA prioritizes quick trials for variant-specific COVID-19 vaccines

FDA has released updated guidance detailing its plans to streamline authorization of COVID-19 vaccines adapted to more-infectious variants, such as the U.K. variant B.1.1.7, which is now present in dozens of states.

FDA’s guidance would require such companies to launch small clinical studies similar to those needed for annual flu vaccines.

It also encourages sponsors to test modified vaccines in unvaccinated as well as previously-vaccinated individuals.

“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement.

Recent data suggest that variant B.1.429, initially found in California, is also more infectious than earlier lineages.

Complicating matters further, B.1.1.7 and B.1.429 have merged in a recombination process to create a new hybrid. Other kno…

FDA issues guidelines to address COVID-19 variants

SARS-CoV-2 image from Wikipedia

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 remain in place and vaccines are being distributed.

“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” acting FDA Commissioner Dr. Janet Woodcock said in a news release. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this …

Pfizer vaccine stable at standard freezer temps, effective with single dose

Pfizer-BioNTech vaccine. Image courtesy of Wikipedia.

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80° C and –60° C, according to current CDC guidelines.

Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would enable vaccine vials to be stored in the warmer temperature range for up to two weeks, reducing the need for ultracold freezers, which are in short supply.

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

Pfizer-BioNTech COVID-19 vaccine stable at standard freezer temps

Pfizer-BioNTech vaccine image courtesy of Wikipedia

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80⁰ C and –60⁰ C, according to current CDC guidelines.

Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would enable vaccine vials to be stored in the warmer temperature range for up to two weeks, reducing the need for ultracold freezers, which are in short supply.

“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” said BioNTech CEO Ugur Sahin in a statement. “We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.”

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Biden announces $4B to support global vaccinations worldwide

[Photo by Daniel Schludi on Unsplash]President Joe Biden announced that the U.S. is set to provide $4 billion to the COVAX Facility to support access to safe and effective COVID-19 vaccines.

Money appropriated by a December 2020 Congressional vote will comprise an initial $2 billion contribution to Gavi, the Vaccine Alliance for the COVAX advance market commitment (AMC) covering 92 low- and middle-income economies, according to a White House Statement.

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

Biden announces $4B to support global vaccinations worldwide

President Joe Biden announced that the U.S. is set to provide $4 billion to the COVAX Facility to support access to safe and effective COVID-19 vaccines.

Money appropriated by a December 2020 Congressional vote will comprise an initial $2 billion contribution to Gavi, the Vaccine Alliance for the COVAX advance market commitment (AMC) covering 92 low- and middle-income economies, according to a White House Statement.

Additionally, the U.S. will release a further $2 billion through 2021 and 2022, with the first $500 million set to be made available when existing donor pledges are fulfilled and initial doses are delivered to AMC countries.

Biden also called on the G7 and other partners to work alongside Gavi to continue to build support for global COVID-19 vaccination, targeting urgent vaccine manufacturing, supply and delivery needs.

“The United States’ contribution is designated to help Gavi prevent, prepare for, and respond to coronavirus th…

Pfizer, BioNTech start trial to evaluate COVID-19 vaccine’s effect on pregnant women

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women.

The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine in preventing COVID-19 in healthy pregnant women 18 years of age and older, according to a news release.

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

Pfizer, BioNTech start trial to evaluate COVID-19 vaccine’s effect on pregnant women

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women.

The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine in preventing COVID-19 in healthy pregnant women 18 years of age and older, according to a news release.

Pfizer and BioNTech’s Phase 2/3 trial is a randomized, placebo-controlled, observer-blind study in approximately 4,000 healthy pregnant women vaccinated during 24 to 34 weeks of gestation. The study will evaluate the safety, tolerability and immunogenicity of two doses administered 21 days apart.

Each participant will be involved in the study for approximately seven to 10 months, depending on whether she was randomized to receive the vaccine or a placebo. The study will also assess the saf…