COVID-19 vaccine Archives - Page 5 of 38

Pfizer-BioNTech omicron-based vaccine may be delayed

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have launched a clinical trial to test an omicron-specific version of their COVID-19 vaccine.

The two companies initially vowed to launch the updated vaccine by the end of March, but that goal may shift depending on the volume of clinical data regulators demand, according to BioNTech.

In the meantime, a number of countries have begun administering a fourth COVID-19 vaccine dose to immunocompromised individuals. In addition, Israel and Denmark have started offering a fourth dose to the public.

The European Medicines Agency (EMA) has stated it wants to see data showing that updated vaccines lead to higher neutralizing antibody levels than first-generation vaccines while potentially bolstering the protection against emerging variants.

Moderna is also working on an omicron-specific vaccine, but it won’t likely be available until August.

FDA hits pause on COVID-19 vaccine for children under 5

FDA may wait several months before deciding to authorize a COVID-19 vaccine for children between the ages of 6 months to 4 years.

The agency had planned on adjourning a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the potential use of the vaccine in younger children.

But FDA decided to postpone the meeting until further notice after Pfizer (NYSE:PFE) shared new data related to its emergency use authorization (EUA) request for an ongoing clinical trial testing the Pfizer-BioNTech vaccine in young children.

FDA indicated in a statement that it wants to review data related to a third dose of the vaccine to foster “a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines.”

The agency noted that evaluating initial data from the clinical trial was “useful,” but “at this time, we believe additional information regarding the ongoing evaluatio…

Johnson & Johnson pauses COVID-19 vaccine production in Dutch plant

Johnson & Johnson (NYSE:JNJ) has decided to temporarily suspend production of its COVID-19 vaccine in Leiden in the Netherlands to prioritize production of an investigational respiratory syncytial virus (RSV) vaccine, according to The New York Times.

The plant will resume production of its COVID-19 vaccine in a matter of months, the paper reported. The company is also working to enlist other facilities to help produce the vaccine, but they are either currently not operational or haven’t received regulatory approval.

While the J&J vaccine has failed to find widespread use in wealthy countries, it remains popular in portions of the developing world, including much of Africa. The vaccine has less-demanding storage requirements than the first generation of mRNA vaccines and offers robust protection against a range of variants when administered as a two-dose series.

Image courtesy of Wikimedia Comm…

Omicron-specific mRNA vaccine elicited similar protection as original in early primate study

A scanning electron microscope image shows SARS-CoV-2 (yellow). Credit: NIAID-RML

An NIH authored preprint concluded that an omicron-specific version of Moderna’s (NSDQ:MRNA) vaccine might not offer improved immunity or protection compared to the company’s current mRNA-1273 vaccine.

In a small study involving macaques, NIH researchers tested neutralizing antibody levels and B cell expansion in primates receiving mRNA-1273 and mRNA-1273.529, the updated vaccine.

The study involved a total of eight macaques who received two initial 100-μg doses of the mRNA-1273 vaccine. Nine months after the second dose, four primates received a dose of the existing vaccine, while the remaining four received the omicron-based version.

The study authors performed a challenge test, exposing the non-human primates to the omicron variant to gauge their immune response. The researchers ultimately concluded that both…

FDA could authorize Pfizer-BioNTech vaccine for young children in late February

The FDA has requested that Pfizer apply for emergency authorization for the BNT162b2 vaccine for children 6 months of age to 5 years old, according to media reports.

The agency is awaiting data from a third dose of the vaccine in the age group, which could be available in March.

Pfizer could apply for emergency use authorization as soon as tomorrow and win authorization by the end of February, according to The Washington Post.

In December, Pfizer and its partner BioNTech (NSDQ:BNTX) announced that an independent data monitoring committee concluded the study met non-inferiority requirements for the 6- to 24-month-old group but not for the 2- to under 5-year-old group.

The vaccine was well tolerated in the young age group.

Recipients in the trial are receiving 3 µg doses of mRNA, which is one-tenth the amount used in adults.

For 5- to 12-year-olds, the authorized dose is 10 µg.

The first two doses are administered 21 days…

Study bolsters case that vaccines protect against long-COVID

A scanning electron microscope image shows SARS-CoV-2 (yellow). Credit: NIAID-RML

It may be too soon to know how often the omicron variant is associated with so-called long-COVID, but research from the Leavitt Partners’ COVID-19 Patient Recovery Alliance confirms that vaccination protects against the condition.

Those who received at least one authorized COVID-19 vaccine dose before diagnosis were between seven and 10 times less likely to report two or more long-COVID-19 symptoms, according to the preprint study conducted before the surge of the delta variant.

Those who received a vaccine four weeks after diagnosis were four to six times less likely to develop the condition.

There are limits to how well researchers understand the condition given the fuzziness of the definition of long-COVID and the continual emergence of SARS-CoV-2 variants, said Michael A. Simon, principal data scientis…

Israeli advisory committee backs fourth dose of COVID-19 vaccine

Photo by cottonbro from Pexels

Israel could be one of the first countries to begin administering a fourth dose of COVID-19 vaccine to individuals over 18 after an advisory committee decision.

Before the decision becomes binding, the director of Israel’s Ministry of Health, Nitzan Horowitz, must sign off on the recommendation.

If implemented, Israeli adults would be eligible for a fourth dose five months after receipt of the third dose or recuperating from a COVID-19 infection.

In making its decision, the panel cited data from Sheba Medical Center that shows a fourth dose of the Pfizer-BioNTech COVID-19 vaccine yields a three- to five-fold increase in protection against severe disease. A fourth dose, however, is unlikely to offer robust protection against infection.

While Israel has already begun providing a fourth dose to immunocompromised people, healthcare workers, and those over 60, H…

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…

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…

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.

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…

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