Pfizer highlights COVID-19 and flu vaccine strategy in Q2 earnings call

With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call.

While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during the Q2 call yesterday.

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Pfizer highlights COVID-19 and flu vaccine strategy in Q2 earnings call

With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call.

While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during the Q2 call yesterday.

Pfizer working on an mRNA flu vaccine

Pfizer began working with BioNTech (NSDQ:BNTX) to develop an mRNA-based flu vaccine in 2018. The mRNA platform could boost flu vaccine efficacy and lead to a better immune response. Traditional flu vaccines are between 40% and 60% effective among the overall population, according to the CDC.

The company aims to launch human trials for a modified RNA flu vaccine in the third quarter of the year.

Delta variant concerns

Pfizer is currently running a clinical trial to test the use of a third dose of its vaccine six to 12 months…

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Preprint shows strong but fading efficacy of Pfizer vaccine at six months

An ongoing study involving the BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) could potentially underscore the need for boosters. But more data are needed to understand vaccine performance over time, according to a preprint published on MedRxiv.

Pfizer CEO Dr. Albert Bourla has previously predicted that booster doses of the vaccine would be needed. Still, the U.S. government has yet to embrace that view for the general population. A CDC advisory committee, however, recently endorsed the use of boosters in immunocompromised patients.

The study found that the efficacy of the BNT162b2 vaccine peaked between seven days to less than two months after the administration of the second dose. Four-to-six months after the second dose administration, the efficacy waned to 83.7%. Efficacy declined an average of roughly 6% every two months, according to the paper. “Ongoing follow-up is needed to understand persistence of the vaccine effect over tim…

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Pfizer and Moderna to expand clinical trials for school-aged children 

As a result, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have agreed to expand clinical trials of their vaccines in children aged five to 11 before seeking emergency use authorization.

In April, Israel first reported suspected cases of heart inflammation in recipients of the COVID-19 vaccine from Pfizer and its partner BioNTech.

Since then, FDA has substantiated the risk of myocarditis, or heart inflammation, from mRNA vaccines, which is rare and tends to be minor.

According to The New York Times, federal regulators concluded that the proposed clinical trials to study the Pfizer and Moderna vaccines in school-aged children were insufficiently powered to detect rare side effects, including heart inflammation.

[Related: AstraZeneca, Pfizer Moderna vaccines fare well against Beta, Gamma and Delta variants in study]

Pfizer (NYSE:PFE) and BioNTech (NASDAQ: BNTX) announced in June that it was expanding its COVID-19 vaccine trial to include up to 4,…

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AstraZeneca, Pfizer Moderna vaccines fare well against Beta, Gamma and Delta variants in study

A recent Canadian pre-print study found that AstraZeneca’s Vaxzevria vaccine was 82% effective in preventing hospitalization or death from the Beta and Gamma SARS-CoV-2 virus variants. Using the same benchmark, its efficacy against the Alpha and Delta variants was 87% and 90%, respectively, 21 days after administering the first dose.

The BNT162b2 vaccine from Pfizer and BioNTech had a similar efficacy after 21 days. In terms of protecting against the Beta and Gamma variants, a single dose of the BNT162b2 vaccine was 83% effective at protecting against hospitalization and death after 21 days. One dose of Moderna’s mRNA-1273 vaccine was 94% effective at the same interval.

A second dose of the Pfizer-BioNTech vaccine boosted its efficacy considerably. It was 98% effective at preventing hospitalization or death from the Beta and Gamma variants 14 days after the second dose. Its protection against other variants was similar following the second dose.

There wa…

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Man experiences facial palsy twice after receiving both COVID-19 vaccine doses

Representational Bell’s palsy image courtesy of Wikipedia

The possibility of mRNA causing facial palsy continues to make headlines. A month after a JAMA study found no link between the Pfizer-BioNTech vaccine and facial paralysis, an article in BMJ Case Reports describes the case of a 61-year-old U.K. man who experienced facial palsy episodes after receiving both doses of the Pfizer-BioNTech vaccine.

The journal reports that the case report is the first to describe unilateral facial nerve palsy after both doses of the Pfizer-BioNTech vaccine.

In the Phase 3 trial for the Pfizer-BioNTech vaccine, four patients who received the injection developed Bell’s palsy while none in the placebo arm did. There were approximately 38,000 participants in that study.

In the case of the 61-year-old man, he experienced facial paralysis on the right side five hours after receiving the first dose. The …

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Pfizer-BioNTech to provide U.S. with another 200M shots for kids, boosters

[Image courtesy of Wikipedia]Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. government has purchased another 200 million doses of their COVID-19 vaccine.

Media outlets including CNN and the Financial Times cited a Biden administration official saying the additional doses are needed to vaccinate children under 12, pending FDA authorization, plus the potential need for additional booster shots against variants. In a recent CNN interview, President Joe Biden predicted that the government will OK vaccines for young children in the next few months; Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases told a Senate panel that it could be by early winter.

Get the full story on our sister site Pharmaceutical Processing World. 

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Pfizer-BioNTech to provide U.S. with another 200M shots for kids, boosters

Pfizer-BioNTech vaccine [Image courtesy of Wikipedia]

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. government has purchased another 200 million doses of their COVID-19 vaccine.

Media outlets including CNN and the Financial Times cited a Biden administration official saying the additional doses are needed to vaccinate children under 12, pending FDA authorization, plus the potential need for additional booster shots against variants. In a recent CNN interview, President Joe Biden predicted that the government will OK vaccines for young children in the next few months; Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases told a Senate panel that it could be by early winter.

Pfizer and BioNTech expect to deliver the additional doses from October 2021 through April 2022, bringing the total doses purchased by the U.S. government for the American public to…

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Biovac to make and distribute Pfizer-BioNTech COVID-19 vaccine in Africa

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) today announced an agreement with Biovac to manufacture the companies’ COVID-19 vaccine for distribution in Africa.

Cape Town, South Africa-based Biovac will perform manufacturing and distribution activities within Pfizer and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network to aid in distribution within the African Union, according to a news release. The technical transfer, on-site development and equipment installation activities for Biovac will begin immediately.

Pfizer and BioNTech’s global vaccine supply chain and manufacturing network now spans three continents, the companies said, with more than 20 million manufacturing facilities.

They expect Biovac’s Cape Town facility to be incorporated into the COVID-19 vaccine supply chain by the end of 2021, with Biovac slated to obtain drug substance from European facilities. The manufacturing of finished doses will c…

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BioNTech to buy Kite’s neoantigen TCR cell therapy R&D platform and Maryland plant

BioNTech (NSDQ:BNTX) announced today that it acquired Kite’s solid tumor neoantigen T cell receptor (TCR) platform and its facility in Maryland.

Mainz, Germany-based BioNTech said in a news release that the acquired clinical manufacturing facility in Gaithersburg, Md., will provide production capacity in support of U.S. clinical trials while complementing the company’s existing cell therapy manufacturing facility in Idar-Oberstein, Germany.

Kite’s Maryland facility will also support the development of BioNTech’s expanding pipeline of novel cell therapies, including cancer product candidates based on its CAR-T cell amplifying mRNA vaccine (CARVac) and Neostim platforms, as well as the newly acquired, individualized neoantigen TCR program.

The company said that all Kite employees at the Gaithersburg plant will be offered employment with BioNTech prior to the closing of the acquisition, while it also plans on further …

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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…

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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…

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