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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Pfizer shares surge on strong Q2

Pfizer (NYSE: PFE) posted second-quarter results today that beat the consensus forecast. In addition, thanks to solid vaccine sales, the company boosted its outlook for the remainder of the year. The company expects annual sales of the two-dose vaccine it jointly developed with BioNTech to hit $3.5 billion.

The New York City–based company reported profits of $5.563 billion, or $0.98 per share, on sales of $19.0 billion for the three months ended June 30, for a bottom-line gain of 59% and operational growth of 86% compared with Q2 2020.

Adjusted diluted earnings per share were $1.07, eight cents ahead of The Street, where analysts were looking for EPS of $0.99 on sales of $9.9 million.

“I couldn’t be prouder of the way Pfizer has started 2021,” said Pfizer CEO Dr. Albert Bourla in the earnings call.

While COVID-19 vaccine sales drove the majority of its growth in the second quarter, Bourla said the company is “equally proud of the second-quarter pe…

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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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Big pharma resists international corporate tax proposal

Image from https://torange.biz/medications-big-money-19928

Pharma companies are resisting a tentative agreement between 130 countries to create a minimum corporate tax of 15%. The plan intends to combat tax inversion and other forms of tax avoidance.

Some U.S. industries, including Big Tech, have backed the plan given its potential to simplify accounting — even if it increases their tax rate.

But the pharma industry is highlighting its role in developing COVID-19 vaccines and other therapies in their opposition to the plan. Arguing that higher taxes would curb their ability to innovate, drug companies are worried about the proposal’s threat to their bottom line. Large pharma companies could see their tax bill increase by hundreds of millions of dollars annually if the plan is finalized. Moreover, pharmaceutical companies could see a larger tax hike than some other industries given their global presenc…

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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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Mix-and-match COVID vaccines attract support and backlash

Image courtesy of Pexels

Several countries have embraced the idea of using distinct COVID-19 vaccines for the first and second doses. But a death in Korea is fueling concerns about the strategy, and some public authorities have warned against the practice.

Canada, Korea, Thailand and Germany have authorized the use of a heterologous prime-boost COVID-19 vaccination strategy to manage supply constraints.

A police officer in South Korea, however, has died after receiving first an AstraZeneca vaccine dose followed by a Pfizer dose, according to The Korea Times. Health authorities there will investigate the death of the 52-year-old officer, who passed away three days after receiving his second vaccine dose.

A recent preprint study published in The Lancet suggested that combinations of AstraZeneca and Pfizer vaccines were effective. Data, however, are preliminary.

Germany, Canada and Thailand…

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34 of the most innovative pharmaceutical products

Photo by Myriam Zilles on Unsplash

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to make its selections.

The organization will announce final winers in the competition at ceremony in New York City on October 28, 2021. 

In terms of pharmaceutical agents, the organization selected the following 34 nominees:

Company Drug name

AbbVie Inc.

Rinvoq (upadacitinib)

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma 

Adhansia XR (methylp…

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