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Novax could have one of the most-effective COVID-19 vaccines

Novavax may not be the best-known vaccine developer, but its COVID-19 vaccine offers performance in line with those from Moderna and Pfizer. Its vaccine was 96.4% effective at preventing COVID-19 caused by the original strain of the virus in a Phase 3 study. The Moderna and Pfizer vaccines offered efficacy in the mid-90% range in similar studies.

But in the efficacy of the Novavax NVX–CoV23 vaccine dipped to 86.3% when it came to protecting against the U.K. variant (B.1.1.7).

Because of subtle differences in trial designs and timing, it is difficult to do head-to-head comparisons of clinical trials. The Phase 3 clinical trial results for the Moderna and Pfizer-BioNTech vaccines did not include data on SARS-CoV-2 variants.

In a separate Phase 2b trial in South Africa, the Novaax vaccine has an efficacy of 55.4% in HIV- negative trial volunteers. The majority of COVID-19 cases in the country are the result of the B1.351 variant. The South Africa and Brazil…

Why emergency authorization of COVID-19 therapies could pose regulatory questions

Image by Arek Socha from Pixabay

Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications.

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard,” said Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland.

The FDA’s decision to grant emergency use authorization to investigational vaccines could lead to the development of a “marketplace” where vaccines are deemed “good enough to be authorized, but never approved,” Doshi opined in the public comment period of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Johnson & Johnson’s vaccine.

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

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…

NIH starts Phase 3 trial of blood clotting treatments for COVID-19

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The NIH announced today that it has launched the last of three Phase 3 clinical trials to evaluate the safety and effectiveness of blood thinners to prevent life-threatening blood clots in adults diagnosed with COVID-19.

As part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, the trial will study the use of Bristol Myers Squibb/Pfizer’s Eliquis blood thinner in patients discharged from the hospital following a case of moderate-to-severe COVID-19. The other two ACTIV studies already underway involve hospitalized COVID-19 patients and people with COVID-19 who have not been hospitalized.

The trials are taking place at more than 100 sites worldwide.

Researchers noticed early in the COVID-19 pandemic that many people who died has blood clots throughout their bodies — clotting that can cause multiple health c…

Is there a link between Bell’s palsy and COVID-19 vaccines?

Image courtesy of Nataliya Vaitkevich via Pexels.

One adverse event common to clinical trials for currently authorized COVID-19 vaccines is Bell’s palsy, an asymmetrical weakness or paralysis of the face that is often temporary.

Two vaccine recipients in the Johnson & Johnson Phase 3 clinical trial developed Bell’s palsy, as did two people in the placebo group. Another patient developed facial swelling and “droopiness” without facial asymmetry. A clinical trial investigator concluded that this event was unrelated to the vaccine.

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

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…

Why focusing on the quantity of pharma innovation is misleading

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Since the early 2000s, pundits have lamented that there is an innovation crisis in the pharmaceutical industry. One of the most common reasons given is the challenge of bringing new drugs to market.

The U.S. Government Accounting Office concluded in 20016 that the “productivity of [the pharma industry’s] research and development expenditures has been declining.” The cost of developing a new drug frequently tops $1 billion, and scores of drug candidates never make it to market.

While the COVID-19 pandemic has heightened society’s appreciation for the pharmaceutical industry’s innovation, the concept of an innovation crisis hasn’t gone away.

Many of the arguments purporting such a crisis focus on the quality of pharmaceutical innovation rather than its quantity, said Troy Groetken, a shareholder, board member, and executive committee member at the intellectual prop…

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.