Pfizer Archives - Page 20 of 33 - Medical Design Sourcing

Pfizer, subsidiaries agree to pay $345M in EpiPen pricing lawsuit

Pfizer (NYSE:PFE) agreed to pay $345 million to settle claims of overpayments for EpiPens due to alleged anti-competitive and unfair practices.

Reuters reported that a filing disclosed in federal court in Kansas City, Kan., revealed the settlement set to resolve claims from consumers who say they overpaid for EpiPens with the alleged anti-competitive and unfair practices by Pfizer and its Mylan subsidiary, which markets the EpiPen.

Get the full story at our sister site, Drug Delivery Business News.

Study estimates Pfizer COVID-19 vaccine is 78% effective in pregnant women

A retrospective study published in JAMA concluded that the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) offered statistically significant protection against SARS-CoV-2 infection.

The pivotal trial Pfizer used to win emergency use authorization for the vaccine excluded pregnant women. COVID-19, however, increases the risk of pregnancy-related complications — particularly in the third trimester.

To determine how the vaccine performs in pregnant women, researchers in Israel tracked 7,530 vaccinated and 7,530 unvaccinated expectant mothers. They counted 118 COVID-19 infections in the vaccinated group and 202 in the control group. Researchers recruited volunteers from Maccabi Healthcare Services (Tel Aviv).

Among the two groups of women with PCR-confirmed COVID-19 infections, between 83% and 84% were symptomatic.

Some 68 patients receiving the vaccine complained of adverse events. None of them, however, were severe.

The resea…

Israel recommends third COVID-19 vaccine dose for the immunocompromised

Photo by cottonbro from Pexels

Israel is following a similar path to the U.K. in its plans to administer a third dose of COVID-19 vaccine to a subset of patients.

U.K. officials recently announced their initiative to provide a booster to high-risk patients, but those plans are preliminary.

Both Israel and U.K. have concluded that fully vaccinated individuals are unlikely to require a booster dose later this year.

The Israeli government, however, is taking more definitive steps in issuing guidance for people who are immunocompromised to receive a third dose of the vaccine from Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX). Some medical centers have already begun administering boosters to those who are severely immunocompromised including cancer patients and recipients of organ transplants. While the country is considering providing a third dose for those 60 and older, it hasn’t yet reached a d…

Pfizer to ask FDA to authorize booster dose of its COVID-19 vaccine

Pfizer (NYSE:PFE) has said that the efficacy of its vaccine wanes after six months in the presence of contagious variants such as Delta. The company and its German partner plan on using that justification to ask FDA to extend their EUA for their COVID-19 vaccine to cover a booster dose of their mRNA vaccine.

Reuters quoted Pfizer Chief Scientific Officer Mikael Dolsten as saying that a recent uptick in COVID-19 cases in Israel is evidence that the vaccine offers less protection against the Delta variant — especially in those vaccinated six months ago or earlier.

After six months, “there likely is the risk of reinfection as antibodies, as predicted, wane,” Dolsten said.

Israel’s Health Ministry shared data on July 5 that indicated that the Pfizer-BioNTech vaccine remained effective at preventing serious COVID-19 infections, but that it was less effective overall against the Delta variant.

Early Pfizer experiments show that a third dose of BNT…

Several companies could vy for next-gen COVID-19 vaccine market share

[Photo by Daniel Schludi on Unsplash]

A couple of years ago, mRNA vaccines remained at the research stage. Now, they are among the best-selling pharmaceutical products with Pfizer (NYSE:PFE), BioNTech (NSDQ:BNTX) and Moderna (NSDQ:MRNA) dominating the market.

That could change in the long run, however, as a growing number of companies develop next generation mRNA COVID-19 vaccines, which promise to be more effective and less likely to cause side effects than their predecessors.

While mRNA COVID-19 vaccines are among the most effective vaccines against the novel coronavirus, researchers have linked their use to rare side effects such as myocarditis.

Future mRNA may be better tolerated. mRNA itself promotes an immune response future mRNA vaccines could optimize reactogenicity through refining the dose or structure of the single-stranded RNA molecule.

Such next-gen vaccines will also likel…

Pfizer to seek to expand COVID-19 vaccine EUA to children aged 5 to 11

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the U.S. emergency use authorization (EUA) for their COVID-19 vaccine to include children aged five to 11.

The companies plan on filing paperwork for the expanded EUA over the coming months. “We are planning for emergency use authorization submission for [children aged five to 11] in September or October of this year, and the [two-to-five-year-old] group to follow soon thereafter,” Alejandra Gurtman, MD, Pfizer’s vice president of vaccine clinical research and development, said during a virtual symposium.

FDA has already authorized the vaccine for people 12 and older.

Pfizer’s Phase 1/2/3 study testing vaccine safety and efficacy in children has enrolled approximately 4,500 participants aged six months to 11 years old. Some 90 clinical trial sites in the U.S., Poland, Spain and Finland are taking part in the trial.

The Phase 1/2/3 trial involving children aged six months to 1…

CureVac aims to rebound after announcing disappointing COVID-19 results

Some two week after announcing that its COVID-19 vaccine had an interim efficacy of 47% in a Phase 2b/3 trial, CureVac (NSDQ:CVAC) appears to be regaining its footing.

While its stock is trading well below its Feb. 5 peak of $120.43, CVAC shares have risen 30% in the past five days to $75.95 in mid-day trading today.

The company is installing a new chief operating officer, Dr. Malte Greune, who will begin work on July 1, 2021.

Greune will work to bolster CureVac’s board and clinical and manufacturing capabilities.

Greune joins CureVac from Sanofi where he worked in an executive business development role. Gruene has held various leadership positions at pharma companies in the past decade.

Earlier this month, CureVac cofounder Ingmar Hoerr withdrew his candidacy for nomination to the company’s board. Hoerr also served as the company’s CEO from March to August 2020

CureVac has also charged another co-founder, Florian von der…

Pfizer-AstraZeneca COVID-19 vaccine combinations are effective, study suggests

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

British researchers report that using distinct COVID-19 vaccine types for the first and second doses appears to be effective, according to a preprint study in The Lancet.

As global health authorities seek to vaccinate as many people as possible, a potential hurdle is the need to use identical vaccines for the prime and boost stages. Using a so-called heterologous prime-boost vaccination would enable more rapid vaccination, but data about the efficacy of such a strategy have been scarce.

In the recent study, researchers randomized 830 adults 50 and older into eight groups to receive the varying combinations of the AstraZeneca and BioNTech-Pfizer vaccines.

To get a sense of the efficacy of the various combinations, the researchers used a geometric mean ratio (GMR) and geometr…

Pfizer/BioNTech and Moderna vaccines appear to have a durable immune response

[Photo by Daniel Schludi on Unsplash]A new study shows that the Pfizer and Moderna COVID-19 vaccines create an immune response that may protect recipients for years.

The study, published in Nature, revealed that those who received the two-dose mRNA vaccines developed by Pfizer/BioNTech and Moderna could provide immunity for years or even a lifetime in those who were infected with COVID-19 and vaccinated later. However, it remains unclear if vaccination alone has the same long-lasting effect for those who were not infected with the virus beforehand.

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

Pfizer/BioNTech and Moderna vaccines appear to have a durable immune response

[Photo by Daniel Schludi on Unsplash]

A new study shows that the Pfizer and Moderna COVID-19 vaccines create an immune response that may protect recipients for years.

The study, published in Nature, revealed that those who received the two-dose mRNA vaccines developed by Pfizer/BioNTech and Moderna could provide immunity for years or even a lifetime in those who were infected with COVID-19 and vaccinated later. However, it remains unclear if vaccination alone has the same long-lasting effect for those who were not infected with the virus beforehand.

Washington University (St. Louis) immunologist Dr. Ali Ellebedy and colleagues conducted the study, finding that those who survived COVID-19 retained immune cells that recognized the virus in the bone marrow for at least eight months. Another team’s study showed that those “memory B cells” continue to mature and get stronger for at least o…

Pfizer halts global shipments of Chantix over contamination worries

Pfizer (NYSE:PFE) has stopped international shipments of the smoking-cessation drug Chantix (varenicline) after concluding it had elevated levels of a potential carcinogen.

The substance in question, nitrosamines, are organic compounds thought to cause cancer in various organisms.

“We believe the benefits of Chantix/Champix outweigh the very low potential risks, if any, posed by nitrosamine exposure on top of other common sources over a lifetime,” said Pfizer spokesperson Steven Danehy. Champix is the brand name of Chantix outside of the U.S. “We are actively working with regulatory authorities around the world to communicate the appropriate information in accordance with specific actions and timing, which vary by country.”

Pfizer suspended distribution as a precaution. The company is also researching to determine whether additional lots of the drug contain nitrosamines.

Earlier this month, health officials in Canada announced a recall of the drug…

No connection between Pfizer COVID-19 vaccine and Bell’s palsy, study finds

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

A case-control study in Israel found no association between recent vaccination with the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNtech (NSDQ:BNTX) and facial nerve (Bell’s) palsy. JAMA published the study.

Clinical trials for Pfizer-BioNtech and Moderna COVID-19 vaccines revealed numerical imbalances regarding peripheral facial nerve (Bell’s) palsy. In the former Phase 3 trial, which involved approximately 38,000 patients, four patients in the vaccine group developed Bell’s palsy while none in the placebo group did. FDA concluded in a briefing document that the four cases did not rise above the expected rate in the general population but recommended that health officials monitor mRNA vaccine recipients for Bell’s palsy.

To analyze whether the BNT162b2 vaccine resulted in an …