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Pfizer-BioNTech COVID-19 vaccine was 91% effective in 5- to 11-year-olds in Phase 3 study

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have announced that their COVID-19 vaccine was 90.7% effective at protecting against symptomatic COVID-19 in children ages 5 to 11.

The study concluded that a 10-µg dose of the BNT162b2 vaccine, which is one-third the amount authorized for people 12 and older, had the best benefit-risk profile.

Recipients of 20- and 30-µg doses had significantly higher rates of mild or moderate side effects, including fatigue, headache, chills and muscle pain.

The independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet next week to discuss the prospect of recommending the vaccine for use in 5- to 11-year-olds to the FDA.

The BNT162b2 vaccine is currently FDA approved for people 16 and older. An emergency use authorization currently covers children aged 12 to 15.

One concern regarding the use of the vaccine in younger children is its association with myocarditis an…

Novartis to continue manufacturing Pfizer/BioNTech vaccine

Novartis (NYSE:NVS) has announced that it has reached an agreement with BioNTech (NSDQ:BNTX) and Pfizer (NYSE:PFE) to produce their popular COVID-19 BNT162b2 vaccine.

The companies reached a new production agreement that will leave Novartis responsible for fill-and-finish operations related to the mRNA-based vaccine from Pfizer and BioNTech.

Under the agreement, Novartis will produce at least 24 million doses of the vaccine in 2022 in its facilities in Ljubljana, Slovenia.

This year, Novartis had an agreement for the fill and finish of more than 50 million doses.

For the agreement pertaining to 2022, Novartis intends to obtain bulk mRNA from BioNTech to fill into vials under sterile conditions. The company will return the vaccine doses to BioNTech for distribution.

In related news, Pfizer recently announced data from a Phase 3 study, which found that a booster dose of its vaccine was 95.6% effective against COVID-19 in a period when the Del…

ACIP votes unanimously backs GSK’s shingles vaccine Shingrix for immunocompromised adults 19 and older

CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended two doses of GlaxoSmithKline’s (NYSE:GSK) Shingrix (a recombinant adjuvanted zoster vaccine) for adults 19 and older with immunodeficiency or immunosuppression as a result of disease or therapy.

CDC considers Shingrix to be an adult vaccine, and its recommendation is for the adult immunization schedule, which begins at the age of 19.

In addition, ACIP was unanimous in backing Merck’s (NYSE:MRK) and Pfizer’s (NYSE:PFE) pneumococcal vaccines in elderly and immunocompromised adults.

ACIP will share the recommendations with the director of the CDC and the US Department of Health and Human Services for review and approval.

Shingrix first won FDA approval in 2017 to prevent shingles in adults aged 50 and older. In July of this year, the agency extended approval to include adults aged 18 and older with an elevated risk of developing shingles as a result of immunodeficiency …

White House reveals plan to vaccinate children aged 5 to 11

Photo by Aaron Kittredge from Pexels

The White House says that vaccination will be readily available and free of charge for children between the ages of five and 11, assuming the FDA and CDC authorize them.

The authorization of a vaccine for that age group would make 28 million additional Americans eligible for vaccination.

Pfizer recently asked FDA to extend emergency use authorization (EUA) to its vaccine, which it jointly developed with BioNTech.

An FDA advisory committee will convene on October 26 to discuss Pfizer’s request to amend the EUA. While some members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) have signaled concern about the risk of myocarditis linked to mRNA vaccines in children in the past, clinical trial data suggest the vaccines are safe and effective in five- to eleven-year-olds.

The White House said it would begin dispensing shots with…

Lancet study could bode well for mix-and-match COVID-19 vaccination

[Image by Sam Moqadam on Unsplash]

The mRNA vaccines from Pfizer-BioNTech and Moderna appear to work well as a second dose in recipients of a single dose of the AstraZeneca AZD1222 vaccine.

A report in Lancet found that two doses of AstraZeneca’s AZD1222 vaccine were 50% effective. Recipients who received a dose of the AZD1222 vaccine followed by a dose of Moderna’s mRNA-1273 vaccine had adjusted vaccine effectiveness of 79%. Those who received an initial dose of AZD1222 followed by the Pfizer-BioNTech BNT162b2 vaccine saw vaccine effectiveness of 67%.

The report authors stopped short of claiming that a heterologous AZD1222 and mRNA prime-boost vaccination strategy is superior, concluding that it “may be an effective alternative to increase population immunity against COVID-19.”

“These results could have important implications for vaccination strategies and consequently in the battle against the…

AWS and pharma heavyweights join forces on AI-based drug discovery lab

The goal of using AI to transform drug discovery and development may not be novel. But a recent alliance is unique in both the stature of companies belonging to it and its choice of an innovation model.

Big Pharma firms AstraZeneca (LON:AZN), Merck KGaA (ETR: MRK), Pfizer (NYSE:PFE) and Teva (NYSE:TEVA) will partner with Amazon Web Services Inc. (NSDQ:AMZN) and the Israel Biotech Fund (IBF) on what they term a “first-of-its-kind innovation lab” known as AION Labs.

“The launch of AION Labs will provide an opportunity for the healthcare and life sciences industry to uncover new ways to reduce the time and cost for discovery, facilitate open collaboration and interoperability, and ultimately improve patients’ health outcomes,” said Dan Sheeran, director of healthcare and life sciences at Amazon Web Services, in a statement.

AION Labs has also formed a strategic partnership with the biomedical research institute BioMed X (Heidelberg, Germany).

The lab…

FDA appears to be lukewarm on Moderna COVID-19 vaccine boosters

To date, FDA has been cautious in its consideration of COVID-19 vaccine boosters. Now, the agency seems to be staying the course.

In a recently published document summarizing its current view of Moderna’s booster application, the agency concluded that Moderna had not met all of its criteria for authorization.

Rather than taking a position, the agency was ambivalent in its references to Moderna’s (NSDQ:MRNA) request. While a third dose led to higher antibody levels, it did not meet the endpoint of increasing antibody levels sufficiently across a high percentage of study volunteers. Although 88% of recipients had an at least four-fold increase in neutralizing antibody titers with a booster, their seroresponse rate “did not meet the pre-specified immunobridging success criterion,” the FDA document noted.

Moderna’s application asked the agency to authorize boosters for the same populations now eligible for an additional dose of the Pfizer-BioNTech vaccine: a…

Pfizer officially asks FDA to expand COVID-19 vaccine access to younger kids

[Image courtesy of Wikipedia]Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that they submitted a request to the FDA to expand authorization of their COVID-19 vaccine to younger children.

Expanded FDA emergency use authorization would allow for the use of the COVID-19 vaccine candidate, which has full FDA approval for people 16 years of age and older, in children aged 5 to 11. It received EUA for adolescents aged 12 to 15 in May.

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

Pfizer officially asks FDA to expand COVID-19 vaccine access to younger kids

Image courtesy of Wikipedia

Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) announced today that they submitted a request to the FDA to expand authorization of their COVID-19 vaccine to younger children.

Expanded FDA emergency use authorization would allow for the use of the COVID-19 vaccine candidate, which has full FDA approval for people 16 years of age and older, in children aged 5 to 11. It received EUA for adolescents aged 12 to 15 in May.

Last month, the companies announced their plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11, following the submission of initial Phase 2/3 trial data to FDA. Today, in an announcement on Twitter, Pfizer and BioNTech confirmed the official submission of their request for EUA.

With new cases in children in the U.S. continuing to be at a high level, this submission is an …

Voyager Therapeutics’ stock jumps 57% following Pfizer licensing deal

The gene therapy company Voyager Therapeutics, Inc. (NSDQ: VYGR) has reached an agreement with Pfizer (NYSE:PFE) to license novel capsids from its RNA-driven TRACER screening technology.

A capsid refers to the protein shell of a virus protecting its genome.

“We believe that our TRACER platform has the ability to produce not only enhanced blood-brain-barrier penetrant capsids, but also novel capsids with enhanced tropisms across a diversity of tissues and cell types, offering promise to unlock the fullest potential of gene therapies for a wide array of diseases with unmet medical need,” Michael Higgins, Interim CEO of Voyager said in a statement.

TRACER is an acronym for Tropism Redirection of AAV by Cell-type-specific Expression of RNA. AAV is an abbreviation of adeno-associated viruses.

VYGR shares jumped 56.7% apiece to $3.87 on the heels of the announcement.

In the past 12 months, the company’s stock had gradually fallen from $11.90 on O…

EU committee backs Pfizer-BioNTech vaccine booster doses

Pfizer (NYSE:PFE) and BioNTech SE (NSDQ: BNTX) have received a positive opinion from the E.U.’s Committee for Medicinal Products for Human Use (CHMP) for the use of a Comirnaty booster dose in individuals at least 18 years of age at least six months after the second dose.

The European Commission (EC) will likely make a formal decision on the matter soon. Backing from EC will clear the way for Pfizer-BioNTech boosters throughout the E.U.’s 27 member nations.

BioNTech and Pfizer have provided data to European authorities regarding the safety and efficacy of a booster dose of Comirnaty, also known as BNT162b2.

In September, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) considered expanding the approval of the Comirnaty vaccine to include a booster dose with similar criteria. That committee, however, recommended narrowing the scope of boosters to patients facing a higher than average risk of exposure or severe outcomes from C…

India’s Gennova developing mRNA COVID-19 vaccine

India is vying to create domestic mRNA COVID-19 vaccines, with Gennova Bio (Maharashtra) emerging as a frontrunner. The company’s investigational HGCO19 vaccine will be the focus of a Phase 2/3 study.

The vaccine, developed in collaboration with privately-held Seattle-based HDT Bio, has received funding from India’s Department of Biotechnology and Ministry of Science and Technology.

Lyophilized (freeze-dried) HGCO19 has less stringent storage requirements than the vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA), making it a better fit for developing nations.

Gennova’s experimental vaccine is also unique in that it uses self-amplifying mRNA in place of the non-replicating mRNA found in vaccines from Pfizer and Moderna.

Gennova aims to win emergency use authorization for the vaccine candidate in India by the end of the year.

India has also approved a DNA-based vaccine from Zydus Cadila (NSE:CADILAHC) known as ZyCoV-D.

mRNA quic…