COVID-19 vaccines Archives - Page 12 of 24

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,…

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…

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 …

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.

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…

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…

China rebuffs WHO’s plan to continue investigating origins of COVID-19

The possibility that SARS-CoV-2 resulted from a laboratory accident has gained a degree of plausibility among several world leaders.

But China has rejected calls for further investigation into the matter, saying such allegations disregard “common sense,” as Zeng Yixin, vice-minister of the National Health Commission (NHC), said at a press briefing.

White House press secretary Jen Psaki criticized China’s stance, adding in a press briefing that “their position is irresponsible and, frankly, dangerous.”

China has also entertained a theory that Fort Detrick, an Army base in Maryland, is the source of the pandemic.

While the Fort Detrick lab researches infectious viruses, there is no evidence it is the outbreak’s source.

After initially discounting the possibility of the lab-leak scenario, the WHO has recommended further studies in China. Recently, the organization sought to audit laboratories and markets in Wuhan.

The investigation into…

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…

FDA links J&J vaccine to rare cases of Guillain–Barré

The Food and Drug Administration still believes the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, but has concluded that the vaccine is associated with rare cases of Guillain–Barré syndrome. A warning is forthcoming, according to media reports.

Researchers have also linked prior vaccines, including a swine flu vaccine introduced in the 1970s, with the syndrome, which destroys nerves and can cause paralysis and sometimes death. Most frequently, however, the syndrome predominantly affects the lower extremities before ascending to spread muscle weakness. Many people with the condition, however, recover.

Federal officials have concluded that recipients of the Johnson & Johnson COVID-19 vaccine are more likely to contract Guillain–Barré than the background population. A statement from Johnson & Johnson concluded that “the rate of reported cases exceeds the background rate by a small degree.”

FDA stopped short of e…

Why Bioclinica tapped AI in immunotherapy trials early in the pandemic

An AI-based system proved its mettle in screening patients in immunotherapy trials, according to Dan Gebow, chief innovation officer at Bioclinica.

Early in the COVID-19 pandemic, developers of cancer immunotherapies worried that the novel coronavirus would interfere with their clinical trial results.

In previous years, the scientific community established that immunotherapy can rarely cause interstitial lung disease (ILD). An umbrella term covering several conditions such as pulmonary fibrosis that lead to scarring of the lungs, ILD also arises in some patients with COVID-19.

The fact that ILD can arise from COVID-19 and cancer immunotherapies complicated oncology clinical trials, recalled Gebow at Bioclinica, which provides clinical trial adjudication products and services. “Patients in immunotherapy clinical trials were showing up at the emergency room with some type of lung infection,” Gebow said. “You can imagine if you’re the pharmaceutical company…

Pfizer to ask FDA to authorize booster dose of its COVID-19 vaccine

Pfizer (NYSE:PFE) has said that the efficacy of its vaccine wanes after six months in the presence of contagious variants such as Delta. The company and its German partner plan on using that justification to ask FDA to extend their EUA for their COVID-19 vaccine to cover a booster dose of their mRNA vaccine.

Reuters quoted Pfizer Chief Scientific Officer Mikael Dolsten as saying that a recent uptick in COVID-19 cases in Israel is evidence that the vaccine offers less protection against the Delta variant — especially in those vaccinated six months ago or earlier.

After six months, “there likely is the risk of reinfection as antibodies, as predicted, wane,” Dolsten said.

Israel’s Health Ministry shared data on July 5 that indicated that the Pfizer-BioNTech vaccine remained effective at preventing serious COVID-19 infections, but that it was less effective overall against the Delta variant.

Early Pfizer experiments show that a third dose of BNT…

Several companies could vy for next-gen COVID-19 vaccine market share

[Photo by Daniel Schludi on Unsplash]

A couple of years ago, mRNA vaccines remained at the research stage. Now, they are among the best-selling pharmaceutical products with Pfizer (NYSE:PFE), BioNTech (NSDQ:BNTX) and Moderna (NSDQ:MRNA) dominating the market.

That could change in the long run, however, as a growing number of companies develop next generation mRNA COVID-19 vaccines, which promise to be more effective and less likely to cause side effects than their predecessors.

While mRNA COVID-19 vaccines are among the most effective vaccines against the novel coronavirus, researchers have linked their use to rare side effects such as myocarditis.

Future mRNA may be better tolerated. mRNA itself promotes an immune response future mRNA vaccines could optimize reactogenicity through refining the dose or structure of the single-stranded RNA molecule.

Such next-gen vaccines will also likel…