BNT162b2 Archives - Medical Design Sourcing

Pfizer and BioNTech tease next-gen COVID-19 vaccine strategy

As federal officials wax poetic about the prospect of intranasal COVID-19 vaccines and other novel vaccine platforms, Pfizer Inc. (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have announced that a randomized Phase 2 study will study an incrementally improved COVID-19 vaccine known as BNT162b5.

The updated vaccine candidate includes a modified spike protein designed to bolster immunogenicity over the first-generation COVID-19 vaccine.

Pfizer notes that it plans on testing multiple vaccine candidates with the novel spike protein design to offer a more durable and broader immune response against SARS-CoV-2 infections and associated COVID-19.

The companies’ original BNT162b2 vaccine remains one of the most widely used worldwide. In 2021, the vaccine was the best-selling pharmaceutical product, generating $51.1 billion between Pfizer and BioNTech.

The bivalent BNT162b5 vaccine blends RNAs targeting the ancestral strain coronavirus and the omicron …

Pfizer and BioNTech file for EUA for COVID-19 vaccine booster in kids 5 to 11

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11.

The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between 5 and 11, roughly six months after completion of a primary series.

The Pfizer-BioNTech vaccine remains one of the most popular COVID-19 vaccines globally.

FDA authorized an EUA for a primary series of the BNT162b2 vaccine for children 5 to 11 in October 2021.

Pfizer and BioNTech also intend to seek authorization from the European Medicines Agency (EMA) and other regulatory agencies for a booster dose soon.

In the U.S., CDC recently estimated that roughly three-quarters of children had detectable antibodies to SARS-CoV-2, thanks in part to the rapid spread of the omicron variant.

More than half of U.S. adult…

FDA authorizes expanded use of Pfizer-BioNTech vaccine boosters

With the U.S. facing the biggest surge of COVID-19 infections to date, the FDA has decided to amend the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover adolescents aged 12 to 15 and for some immunocompromised children between the ages of 5 and 11. The agency has also reduced the window between the second and third doses from six to five months.

“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing in order to effectively fight COVID-19,” said Acting FDA Commissioner Dr. Janet Woodcock.

To arrive at its decision, FDA analyzed real-world data from Israel, including 6,300 individuals between the ages of 12 and 15 who received a booster dose of the BNT162b2 vaccine at least five months after receiving a second dose.

The authorization for certain immunocompromised child…

Pfizer to test a third dose of COVID-19 vaccine in children 6 months to under 5 years of age

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have found that two 3-µg doses of their BNT162b2 (Comirnaty) vaccine were safe but generated an underwhelming immune response in children aged two to five years old.

PFE shares fell 2.45% to $59.75 in early afternoon trading.

The news could delay vaccine availability for younger children.

As a result, the companies plan on amending a clinical trial to test a third dose of the vaccine at least two months after the second dose.

Pfizer notes that the Phase 1/2/3 study is ongoing and is still blinded.

Pfizer noted that similar clinical data in older age demographics showed higher efficacy with two doses — albeit at higher doses.

On a positive note, a third dose of the vaccine was well tolerated in the trial involving two to five-year-olds.

The companies plan on filing for emergency use authorization in children aged 6 months to under 5 years if the third dose is efficacious. Read more

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…

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.

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…

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…

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 …

Recent study finds Pfizer vaccine effective against Delta variant

The BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) leads to a strong neutralizing antibody response to the B.1.617 variant, according to a recent study published in Nature.

The study focused on the B.1.617.2 subtype of the virus. Two others exist, known as B.1.617.1 and B.1.617.3.

The study did acknowledge that the antibody response to the B.1.617 was less robust than it was for the USA-WA1/2020 strain.

The study concluded that mass immunization with the BNT162b2 vaccine should be a central strategy to end the pandemic.

Researchers first identified the B.1.617 variant in India. The so-called Delta variant now accounts for approximately 6% of COVID-19 infections in the U.S. It is also the dominant variant in the U.K. Various subtypes of B.1.617 exist.

The predominance of B.1.617 in the U.K. underscores its potential to outcompete against B.1.1.7, the so-called “U.K. strain” that became dominant in …

Pfizer-BioNTech COVID-19 vaccine 91.3% effective after six months

The first COVID-19 vaccine to win emergency use authorization in the U.S. is highly effective for at least six months after the second dose. Developed jointly by Pfizer (NYSE: PFE) and BioNTech (NSDQ: BNTX), the BNT162b2 vaccine

The durability of COVID-19 vaccines had been something of an open question, although early clinical data suggested that Moderna’s mRNA-1273 COVID-19 vaccine was effective for at least 90 days after the second dose.

Pfizer plans on releasing more data related to the long-term vaccine immunogenicity in the coming weeks.

Pfizer and BioNTech plan on doing two years of follow-up for their Phase 3 vaccine trial.

Earlier this year, the two companies released data indicating that their vaccine also remains effective against a highly-transmissible SARS-CoV-2 variant first identified in South Africa.

Pfizer and BioNTech are also testing the vaccine on adolescents. Recent data suggest that the vaccine is 100% effective in ad…

Study suggests Pfizer-BioNTech COVID-19 vaccine is effective against emerging variants

A Pfizer-BioNTech preprint published today suggests that their BNT162b2 vaccine will be effective against SARS-CoV2 variants from the U.K. and South Africa, leading to “small differences in viral neutralization” compared with earlier variants.

The U.K variant has been identified in 26 states in the U.S., while the South Africa variant has been found circulating in South Carolina.

The Pfizer and University of Texas Medical Branch scientists conducting the research concluded that modifying the BNT162b2 was unnecessary.

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