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

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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 …

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…

Pfizer and BioNTech submit initial data to FDA on its COVID-19 vaccine and younger children

Pfizer-BioNTech

Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11.

The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA.

The companies last week announced that the vaccine had favorable immunogenicity and tolerability in children 5 to 11.

Vaccine recipients in the clinical trial received a 10-μg dose of mRNA, which is one-third of the amount the company had studied in 16 to 25 year-olds.

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

Pfizer and BioNTech submit initial data to FDA on its COVID-19 vaccine and younger children

Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11.

The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA.

The companies last week announced that the vaccine had favorable immunogenicity and tolerability in children 5 to 11.

Vaccine recipients in the clinical trial received a 10-μg dose of mRNA, which is one-third of the amount the company had studied in 16 to 25 year-olds.

Pfizer and BioNTech also plan to submit the data to a peer-reviewed journal.

The companies expect data from younger children as soon as the fourth quarter of the year.

“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO of BioNTech, in a statement. “The safety profile a…

CDC director recommends boosters for more Americans

CDC Director Dr. Rochelle P. Walensky issued guidelines for COVID-19 boosters, clearing the way for tens of millions of U.S. citizens to obtain a third dose of the Pfizer-BioNTech COVID-19 vaccine.

While FDA and the Advisory Committee on Immunization Practices (ACIP) reached broadly similar conclusions regarding booster doses for seniors and high-risk individuals, Walensky went further. A CDC statement also recommends boosters for people 18 to 49 with underlying medical conditions and people 18 to 64 with a high risk of occupational or institutional exposure.

Dr. Rochelle Walensky

The eligible underlying medical conditions range from having a high body mass index and a history of smoking to HIV and cancer.

Walensky said CDC would review data related to the Moderna and J&J vaccines related to their use as boosters. Both companies have released early data suggesting that boosters of their vac…

Moderna CEO predicts the pandemic will be over in a year

In an interview with the German-language Neue Zürcher Zeitung, Moderna leader Stéphane Bancel shared his predictions about the course of the pandemic.

When asked when the pandemic phase would end, Bancel replied: “As of today, I assume in one year.”

Seniors will need yearly COVID-19 boosters, Bancel said, while the rest of the public will benefit from boosters once every three years.

The durability of COVID-19 vaccines depends on age. Bancel pointed to the coronavirus OC43 as a case in point. The virus, which causes mild-to-moderate respiratory infections, tends to infect older people annually, while younger people about once every three years. “That shows us approximately the path we will tread with COVID-19,” Bancel told the newspaper.

The company is developing a flu vaccine that will cover OC43. In addition, the company is also developing a combination flu–COVID-19 vaccine.

Bancel is confident in the need for boosters, arguing that the e…

Novel COVID-19 vaccine could offer broad immune responses across SARS-CoV-2 variants

The emerging biotech Gritstone Bio (NSDQ:GRTS) has dosed the first patient with its second-generation COVID-19 vaccine known as GRT-R910. The University of Manchester and Manchester University NHS Foundation Trust are jointly overseeing the U.K.-based Phase 1 study.

The GRT-R910 vaccine uses self-amplifying mRNA (SAM), which could optimize antigen expression at lower doses relative to conventional mRNA. The GRT-R910 vaccine targets antigens from the spike protein and highly conserved non-spike proteins on the SARS-CoV-2 virus.

Emeryville, California–based Gritstone believes the vaccine could offer a strong and durable immune response to various SARS-CoV-2 variants. It may also eliminate the need for repeat boosters, the company concluded.

The company believes that the technology will outperform the first generation of mRNA COVID-19 vaccines in those 60 and older.

“Our SAM COVID vaccine is designed to drive robust CD8+ T cell responses, in addition…

COVID-19 vaccines remain a cash cow for now

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

A handful of companies are making billions of dollars in revenues from COVID-19 vaccines. Especially well-positioned is Pfizer, which could earn $33.5 billion in COVID-19 vaccine sales this year, as it announced in its Q2 earnings statement. By contrast, J&J has forecasted $2.5 billion in COVID-19 vaccine sales this year, while AstraZeneca has seen sales of $1.1 billion in the first half of this year, according to Moody’s.

Analysts are divided, however, on how strong vaccine sales will be in 2022 and beyond.

A report from Moody’s predicts that vaccine sales next year will begin to wane given significant vaccine penetration rates and uncertain demand for boosters. Vaccine penetration rates in many G20 countries have already surpassed 60%. As a result, COVID-19 vaccine revenue i…

FDA advisory panel recommends boosters only for older and high-risk individuals

Doses of the COVID-19 vaccine are seen at Walter Reed National Military Medical Center, Bethesda, Md., Dec. 14, 2020. (DoD photo by Lisa Ferdinando)

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19.

The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals 16 years of age and older. A total of 16 panelists voted ‘no’ while two others voted ‘yes.’

“With regard to the extrapolation of data from much older populations to 16- and 17-year-olds, we have no data on the safety in these populations at all that have been presented so far. And that concerns me significantly,” said Dr. Archana Chatterjee, VRBPAC member and dean of the Chicago Medical School. While supporting boosters in older populations…

CDC study finds waning immunity in Pfizer-BioNTech vaccine recipients after four months

CDC today released comparative effectiveness data for the three COVID-19 vaccines available in the U.S. in individuals without immunocompromising conditions.

The CDC concluded that, from March 11 to August 15, the Moderna vaccine was 93% effective. The Pfizer-BioNTech and Janssen vaccines had lower effectiveness rates of 88% and 71%, respectively. The research also found that post-vaccination anti-spike IgG and anti-RBD IgG antibodies levels were “significantly lower” for Janssen vaccine recipients than those who received mRNA vaccines

Drawing data from more than 3,600 adults, the study interpreted vaccine efficacy as protection against hospitalization.

The report noted that all three COVID-19 vaccines available in the U.S. prevented hospitalization based on data from 21 hospitals.

The study also found that protection from the Pfizer-BioNTech vaccine dipped four months after vaccination to 77%. The effectiveness of the Moderna vaccine at that inte…

FDA advisory panel recommends boosters only for older and high-risk individuals

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

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19.

The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals 16 years of age and older. A total of 16 panelists voted ‘no’ while two others voted ‘yes.’

“With regard to the extrapolation of data from much older populations to 16- and 17-year-olds, we have no data on the safety in these populations at all that have been presented so far. And that concerns me significantly,” said Dr. Archana Chatterjee, VRBPAC member and dean of the Chicago Medical School. While suppo…