CHMP backs updated Pfizer/BioNTech and Moderna COVID-19 boosters

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EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing bivalent COVID-19 vaccines from Pfizer/BioNTech and Moderna.

The boosters target the omicron BA.1 sublineage.

Assuming the European Commission follows CHMP’s recommendations, the European vaccine campaign will use bivalent vaccines targeting the original version of the omicron variant.

U.S. regulators, by contrast, have backed the use of bivalent vaccine boosters that target the BA.4/BA.5 sublineages of omicron. While Pfizer/BioNTech (NYSE:/PFE, Nasdaq: BNTX) and Moderna (Nasdaq:MRNA) have both developed vaccine boosters based on BA.4/BA.5, there is currently no human data for those vaccines. Instead, FDA is relying on data from earlier vaccine versions and preclinical data.

EMA’s recommended that the updated boosters be used in individuals at least 12 years of age who have…

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FDA reportedly will soon authorize updated COVID-19 boosters

The FDA is on the verge of authorizing updated COVID-19 boosters without the benefit of Phase 3 clinical trial data, according to media reports.

The bivalent boosters, based on the omicron sublineages BA.4 and BA.5 and the original form of SARS-CoV-2, could be available soon after Labor Day.

To authorize the omicron-specific COVID-COVID-19 boosters, FDA will likely review data from the first-generation mRNA COVID-19 vaccines, investigational omicron-specific boosters based on the BA.1 variant and preclinical research.

Moderna (Nasdaq:MRNA) is developing an updated COVID-19 vaccine, as are Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX).

The agency hopes the boosters will offer a similar level of protection against SARS-CoV-2 that COVID-19 vaccines provided when they were first authorized in late 2020. At that point, the novel coronavirus had mutated relatively little, resulting in strong vaccine-induced immunity.

The emergence of m…

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FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall

[Photo from Pexels]The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

FDA today followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.

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

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FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11

Pfizer-BioNTech

The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine.

The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said FDA Commissioner Robert M. Califf in a news release.

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

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Moderna shares R&D updates at third annual vaccines day

Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old. Efficacy fell to 37.5% in children aged 2 to 6.

As part of a series of Vaccine Day–themed announcements, the company said it is making progress with global regulatory submissions for the mRNA-1273 in younger children. The company hopes to receive authorization for a 25 μg two-dose primary series of the COVID-19 vaccine. 

In addition, the company is vying to get FDA authorization for children 6 to 12 years old. The shot is already approved for that demographic in Europe, Canada and Australia. 

In addition, an interim analysis of a Phase 2 study of influenza vaccine candidate mRNA-1010 found no significant safety concerns. Furthermo…

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FDA advisory panel to convene to consider second booster dose

[Photo by Daniel Schludi on Unsplash]The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to discuss the potential use of COVID-19 vaccine booster does.

Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) are seeking to amend the emergency use authorization of their respective vaccines to allow for an additional booster.

Pfizer and its partner BioNTech SE (Nasdaq:BNTX) are seeking authorization for a second booster in adults 65 and older, while Moderna is hoping FDA will authorize a second booster in adults 18 and older.

Get the full story from our sister site, Pharmaceutical Processing World. 

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FDA advisory panel to convene to consider second booster dose

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to discuss the potential use of COVID-19 vaccine booster does.

Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) are seeking to amend the emergency use authorization of their respective vaccines to allow for an additional booster. 

Pfizer and its partner BioNTech SE (Nasdaq:BNTX) are seeking authorization for a second booster in adults 65 and older, while Moderna is hoping FDA will authorize a second booster in adults 18 and older. 

The VRBPAC does not plan to discuss any product-specific applications, and there is no vote scheduled for the meeting. 

Instead, the VRBPAC will discuss broader considerations. In particular, they will focus on the timing and populations for booster doses in the coming months and what criteria might dictate when COVID-19 vaccines need to be updated based on circulating SARS-CoV-2 variants. 

“Now is the time to…

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

Photo by Frank Meriño from Pexels

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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CDC director recommends boosters for more Americans

CDC Director Dr. Rochelle P. Walensky issued guidelines for COVID-19 boosters, clearing the way for tens of millions of U.S. citizens to obtain a third dose of the Pfizer-BioNTech COVID-19 vaccine.

While FDA and the Advisory Committee on Immunization Practices (ACIP) reached broadly similar conclusions regarding booster doses for seniors and high-risk individuals, Walensky went further. A CDC statement also recommends boosters for people 18 to 49 with underlying medical conditions and people 18 to 64 with a high risk of occupational or institutional exposure.

Dr. Rochelle Walensky

The eligible underlying medical conditions range from having a high body mass index and a history of smoking to HIV and cancer.

Walensky said CDC would review data related to the Moderna and J&J vaccines related to their use as boosters. Both companies have released early data suggesting that boosters of their vac…

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