BioNTech and InstaDeep use AI to predict high-risk SARS-CoV-2 variants 

BioNTech (NSDQ:BNTX) and the enterprise AI company InstaDeep have announced that they have created an early warning system to improve the monitoring of potentially dangerous SARS-CoV-2 variants.

The companies claim that the system spotted more than 90% of WHO-designated variants an average of two months before the organization officially classified them. For example, the system classified the omicron variant as “high risk” on the same day its sequence was released.

BioNTech and InstaDeep plan on publishing the research in a peer-reviewed journal. The study is currently available as a pre-print. The paper notes that hundreds of new variants emerge daily, but most do not significantly alter the course of the pandemic.

The AI system considers the structure of the viral variants’ spike protein and their immune escape proclivity.

The two companies used in-house experimental data and public data to test the system’s accuracy.

Dr. Ugur Sahin, CEO …

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WHO concludes that updated COVID-19 vaccines may be needed

When confronting an onslaught of new SARS-CoV-2 variants, COVID-19 vaccine makers such as Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have tested tweaked versions of their vaccines but ultimately decided that they were unnecessary.

Signs are growing that vaccines developed based on the original strain of the novel coronavirus will struggle to offer durable protection against the omicron variant.

A World Health Organization (WHO) technical advisory group concluded that current COVID-19 vaccines might require modification but acknowledged that more research is needed.

In an interim statement, the independent group also concluded that “a vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable.”

The body also urged that governments worldwide ramp up the distribution of current COVID-19 vaccines.

The WHO advisory panel also predicted there were multiple pathways for drug…

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7 potential applications of mRNA-based therapeutics

mRNA image courtesy of Wikimedia Commons.

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory.

Researchers are now exploring dozens of new possibilities for the mRNA platform.

Here, we summarize several areas where mRNA could find use in the coming years.

1. Cardiovascular applications

Image by Raman Oza from Pixabay

Researchers at the University of Pennsylvania recently shared positive data related to the use of mRNA and CAR-T cell therapy to treat cardiac fibrosis in a mouse model.

Last year, AstraZeneca (LON:AZN) announced positive results from a Phase…

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Pfizer and BioNTech set their sights on developing mRNA-based shingles vaccine

Pfizer Inc. (NYSE:PFE) and mRNA vaccine specialist BioNTech SE (NSDQ:BNTX) will collaborate to develop an mRNA-based vaccine to prevent the herpes zoster virus (shingles).

Roughly one million people in the U.S. get shingles each year, according to the CDC.

Currently, the two-dose Shingrix shingles vaccine from GSK (NYSE:GSK) is the only such product available in the U.S. market. Shingrix won FDA approval in 2017.

In 2020, Shingrix generated £1.99 billion ($2.55 billion) in sales internationally.

Pfizer and BioNTech began working together on an mRNA vaccine for influenza in 2018. Two years later, the two companies began work on a COVID-19 vaccine, which has since become one of the bestselling pharmaceutical products in the world.

The shingles mRNA vaccine collaboration will bring together Pfizer’s antigen technology and BioNTech’s mRNA platform.

The two companies will split development costs and plan on beginning clinical trials in th…

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Israeli researchers release data on fourth dose of COVID-19 vaccine

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Early data from Israel’s Sheba Medical Center showed that an additional booster of COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) led to a fivefold increase in antibodies one week after receipt of the vaccine. 

Pfizer had earlier announced that a third dose of the vaccine increased antibody levels 25-fold compared to a two-dose primary series. 

Pfizer and BioNTech, along with their competitor Moderna (NSDQ:MRNA), continue to develop an omicron-specific version of their mRNA vaccine. 

The prospect of a fourth dose of the original vaccine for immunocompetent people may be more controversial than a third. 

While Israel has begun administering a fourth dose to some individuals, the head of the French vaccination program, Dr. Alain Fischer, said there was insufficient evidence at present to recommend an additional vaccine dose. France could dec…

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COVID-19 vaccine makers adjusting to omicron 

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Soon after the omicron emerged, notable companies such as Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced efforts to develop a booster specific to the variant.  

But several pharmaceutical companies are developing custom versions of COVID-19 vaccines for the variant or testing the efficacy of existing vaccines against omicron. 

In October, the Moscow-based Institute of Human Stem Cells announced its plans to test the efficacy of its Betuvax-CoV-2 vaccine against omicron and create a new version of the vaccine if needed.

Inovio (NSDQ:INO) announced in late November 2021 that it would conduct tests of its DNA vaccine candidates INO-4800 and INO-4802 against omicron and that it had begun preclinical development of an omicron-specific vaccine. 

Valneva (NSDQ:VALN) is also testing the ability of its VLA2001 to protect against omicron.  Read more

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100-µg booster dose of Moderna’s vaccine increases antibody levels 83 times against Omicron

Moderna (NSDQ:MRNA) is touting preliminary data suggesting that its COVID-19 vaccine booster led to robust antibody increases against the Omicron variant, both at the 50 µg and 100 µg dose levels.

The 50 µg booster dose, which is currently authorized under emergency use authorization, led to a 37-fold increase compared to pre-boost levels 29 days post-boost. A 100 µg booster dose led to an 83-fold increase in the same time window.

The National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center and Duke University Medical Center conducted the research on sera from 20 booster recipients for the mRNA-1273 vaccine at both 50 µg and 100 µg dose levels.

Two doses of the Moderna vaccine, however, did not offer robust protection against Omicron.

Moderna, like Pfizer, is also developing an Omicron-specific vaccine. Moderna’s is known as mRNA-1273.529.

Moderna anticipates to organize clinical trials for the Omicron-based va…

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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

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CDC’s ACIP deprioritizes Johnson & Johnson’s COVID-19 vaccine

CDC’s Advisory Committee on Immunization Practices (ACIP) voted 15 to 0 to prioritize the Pfizer-BioNTech and Moderna COVID-19 vaccines over Johnson & Johnson’s.

One of the main reasons for the recommendation is a rare side effect associated with the Johnson & Johnson vaccine that results in low blood clots and blood-platelet levels.

CDC officials revealed that there had been 54 cases of the condition, known as thrombosis with thrombocytopenia syndrome.

FDA temporarily paused the use of the vaccine in April over blood clot concerns.

The J&J vaccine has lagged behind the mRNA-based Pfizer-BioNTech and Moderna vaccines in terms of demand.

To date, U.S. health workers have administered 17 million doses of the Johnson & Johnson vaccine compared to 286 million Pfizer-BioNTech doses and 187 million Moderna doses, according to CDC data.

The J&J vaccine also trails its rivals in terms of vaccine efficacy.

That said…

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Pfizer and Moderna keeping a close watch on Omicron COVID-19 variant

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines.

The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein.

“I don’t think the result would be the vaccines don’t protect,” Pfizer CEO Dr. Albert Bourla told CNBC. It is possible, however, that the vaccines could offer less protection against Omicron than other variants such as Delta.

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

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Pfizer and Moderna keeping a close watch on Omicron COVID-19 variant 

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines.

The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein, which

“I don’t think the result would be the vaccines don’t protect,” Pfizer CEO Dr. Albert Bourla told CNBC. It is possible, however, that the vaccines could offer less protection against Omicron than other variants such as Delta.

“Given the large number of mutations, it is highly possible that the efficacy of the vaccine – all of them — is going down,” Stéphane Bancel, Moderna CEO, told CNBC.

If they decide it is necessary, Pfizer and its German partner BioNTech (NSDQ:BNTX) could develop a new vaccine based on Omicron in under 100 days.

Moderna has similar plans.

On November …

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Pfizer-BioNTech COVID-19 vaccine 100% effective in adolescents 12 to 15

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) shared new data from their Phase 3 study of the Comirnaty vaccine, concluding that two 30-µg doses were 100% effective against COVID-19 between seven days and four months after the second dose.

The safety profile of the vaccine in the study was broadly consistent with other clinical safety data. In addition, clinical trial investigators reported no serious safety concerns in participants in the six months following receipt of the second dose.

Data from 2,228 individuals were included in the analysis.

In the U.S., the Comirnaty vaccine is available under emergency use authorization for adolescents 12 to 15. The FDA approved the vaccine for individuals at least 16 years of age in August. In late October, the companies received emergency use authorization for the vaccine in children 5 to 11.

Pfizer and BioNTech plan on including the recent data in a planned supplemental Biologics License Application (sBLA) t…

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