Valneva shares surge 30% after announcing its vaccine candidate neutralized omicron in neutralizing antibody study

Valneva vaccine vials

Valneva SE (NSDQ:VALN) announced promising preliminary lab results involving recipients of its inactivated VLA2001 COVID-19 vaccine.

In a pseudovirus neutralization assay involving sera from 30 volunteers in the Phase 1/2 trial VLA2001-201, all samples had neutralizing antibodies against the ancestral virus and the delta variant. In addition, 87% (26 samples) had neutralizing antibodies to omicron.

VALN shares jumped 30.41% to $42.74 in mid-afternoon trading.

“We continue to believe that VLA2001 could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can,” said Dr. Juan Carlos Jaramillo, chief medical officer of Valneva, in a statement.

Valneva said it was sending data on an ongoing basis to several regulatory agencies, including the European Medicines Agency (EMA) and…

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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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CDC panel recommends COVID-19 boosters for teens

CDC’s Advisory Committee on Immunization Practices (ACIP) voted almost unanimously to support the Pfizer-BioNTech COVID-19 vaccine booster for individuals aged 12 to 17.

As with adults, the recommendation applies to individuals who received the second dose at least five months in the past.

ACIP also recommended that the CDC bolster its suggestion that adolescents between the ages of 16 and 17 receive a booster dose. While the agency had allowed boosters for that age group, it has yet to recommend that all 16- and 17-year-olds receive a booster dose.

The COVID-19 case rate has hit record levels recently, hovering around one million new cases per day.

Assuming CDC director Dr. Rochelle Walensky agrees with the recommendations, adolescents aged 12 to 15 could be eligible to get boosters within days.

 

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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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The top 5 drug discovery stories of 2021

Image courtesy of Pixabay

The pandemic continued to remake the pharma and biotech industry this past year. A handful of companies fared exceptionally well at commercializing COVID-19 therapies. This fact promises to lead to sizable shifts in the rankings of pharma leaders. These trends were not yet evident in our spring roundup of the 50 largest pharma companies, which drew revenue figures from the prior year. But in 2021, companies like Pfizer and Moderna sold tens of billions of dollars of COVID-19 vaccine alone. As a result of the ongoing pandemic, significant shifts are likely in 2022’s forthcoming ranking of pharma leaders.

Here, we provide an opportunity to review the 2021 pharma landscape, including stories that received the most attention on social media.

1. Pharma 50: The 50 largest pharmaceutical companies in the world

The top 50 largest pharmaceutical companies raked in $851 billion…

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Walter Reed research arm’s pan-coronavirus vaccine could hold up against omicron 

Vaccine candidate image from the Walter Reed Institute of Research

The Walter Reed Army Institute of Research (WRAIR) is planning to announce positive early clinical results related to a novel nanoparticle-based COVID-19 vaccine, according to media reports.

A Phase 1 study involving the vaccine found that it was effective against omicron, other SARS-CoV-2 variants and other coronaviruses, including SARS-CoV-1. That study began in April.

A preclinical study involving nonhuman primates was recently summarized in Science.

The Spike Ferritin Nanoparticle (SpFN) COVID-19 vaccine will be the subject of Phase 2 and Phase 3 studies, according to an article from Defense One.

Ferritin is an iron-carrying protein that forms a 24-unit sphere-shaped particle.

WRAIR Is also testing the ferritin nanoparticle–baed platform for vaccines for influenza and the Epstein-Barr virus.

Walter Reed …

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Israel plans to authorize fourth COVID-19 vaccine dose for high-risk populations

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Mere months ago, health experts were divided on whether COVID-19 boosters were necessary for the broader public. 

Then came delta and then came omicron. 

Now Israel is moving to become one of the first countries to offer a fourth dose of COVID-19 vaccine to people at least 60 years old and those at high risk of severe disease. Countries such as Switzerland and the U.K. have reduced the window of time for booster eligibility from six months down to four and three months, respectively. 

As a result, COVID-19 vaccines from companies such as Pfizer and its partner BioNTech, Moderna and others continue to be a hot commodity. 

A number of companies, including Pfizer and Moderna, are also developing omicron-specific versions of their vaccines. Both of those companies are gearing up for clinical trials in early 2022. 

Earlier this month, Pfizer CEO Dr. Al…

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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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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’s COVID-19 antiviral pill could be poised for European regulatory authorization

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided advice about using Pfizer’s COVID-19 antiviral Paxlovid.

CHMP has concluded that Paxlovid (nirmatrelvir/ritonavir) could be used for adults with COVID-19 who don’t need supplemental oxygen and face an elevated risk of developing severe disease.

CHMP also stressed the importance of administering Paxlovid as soon as possible after a COVID-19 diagnosis to boost efficacy.

The guidance, which proceeds marketing authorization, could inform health officials’ planning efforts for Paxlovid.

“The CHMP’s advice signifies the strength of our data for PAXLOVID in the treatment of high-risk adults diagnosed with COVID-19,” said Albert Bourla, Pfizer CEO, in a press release. “If authorized, PAXLOVID has the potential to help save lives and reduce hospitalizations. We look forward to working with the EMA and other regulatory agencies worldwide to bring th…

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UK ramps up booster program to confront surge in COVID-19 cases 

Boris Johnson

U.K. Prime Minister Boris Johnson has announced that the country will accelerate its coronavirus vaccination booster initiative to fight a “tidal wave” of cases resulting from the infectious Omicron variant.

Johnson acknowledged that two doses of vaccine were unlikely sufficient to fight off the recent surge in infections, which hit the second-highest level in the UK since the pandemic began.

In an interview with Sky News, Johnson reported that at least one individual infected with the Omicron variant had died. In the UK, roughly 10 people with the variant have been hospitalized to date.

To date, the country has confirmed 4,713 cases of the Omicron variant, according to Health Secretary Sajid Javid.

Javid reported that the Omicron variant is now responsible for about one in five cases in the UK.

The country will offer fully vaccinated individuals a third dose by the …

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