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Moderna seeks authorization for COVID-19 vaccine in children as young as 6 months old

While a portion of the public is now eligible to receive a second booster dose of COVID-19 vaccine, the FDA has not yet authorized a vaccine for children aged 6 months to 5 years old.

Moderna (Nasdaq:MRNA) is vying to be the first. The company announced today that it is filing a request for emergency use authorization (EUA) for its mRNA-1273 vaccine in young children. The company anticipates that it will complete the filing next week.

The request breaks young children into two groups, with the first covering the ages of 6 months to under 2 years and the second covering kids between 2 and 5 years old. The authorization request refers to a primary series consisting of two 25-μg doses of mRNA-1273.

Moderna also seeks similar authorizations for young children from other international regulatory bodies.

The company is basing the requests on positive interim data from the Phase 2/3 KidCOVE study, which met its primary endpoint.

The study analyzed…

Amazon Web Services is powering medtech innovation: Its chief medical officer explains

Dr. Taha Kass-Hout is the chief medical officer and director of machine learning at Amazon Web Services [Photo courtesy of Amazon]

It doesn’t get any bigger than Amazon in the world of cloud computing.

The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google.

Dr. Taha Kass-Hout, the chief medical officer and director of machine learning at AWS, spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead.

In the following interview, Kass-Hout explains how Moderna was born in the cloud and how the company has used cloud computing to scale mRNA technology.

Get the full story from our sister site, Medical Design …

An Amazon cloud conversation with AWS Chief Medical Officer Taha Kass-Hout

Taha Kass-Hout is the chief medical officer and director of machine learning at Amazon Web Services [Photo courtesy of Amazon]

It doesn’t get any bigger than Amazon in the world of cloud computing.

The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google.

Taha Kass-Hout, the chief medical officer and director of machine learning at AWS, spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead.

“The future is bright for anyone who’s trying to solve problems in healthcare and life science globally,” he said.

This conversation has been edited for clarity and length.

MDO: What d…

Moderna says bivalent COVID-19 boosters could offer more robust protection against variants

Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine.

A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine.

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

Moderna says bivalent COVID-19 boosters could offer more robust protection against variants

Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine.

A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine.

The company continues to develop a vaccine known as mRNA-1273.214 with more omicron-specific mutations. That vaccine candidate is now in a Phase 2/3 clinical trial. The company expects data from that trial to be available in the second quarter.

Moderna has published data related to the mRNA-1273.211 candidate as a preprint study in Research Square.

The company continues to bet that its bivalent booster candidate, mRNA-1273.214, will find use as a booster in autumn 2022 in the Northern Hemisphere.

In any event, the mRNA-1273.211 …

50 of 2021’s best-selling pharmaceuticals

Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments.

Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the COVID-19 vaccine helped catapult Pfizer to be 2021’s top pharmaceutical company. Continued demand for the Pfizer-BioNTech vaccine is likely to keep Pfizer as the biggest pharma firm of 2022 as well. (Look out for more insights from our annual Pharma 50 report.)

The second-best-selling drug of 2021 was AbbVie’s injectable biologic Humira, which generated $20.7 billion in sales. Next in line was Moderna’s COVID-19 vaccine, which drove $17.7 billion in revenue. Merck’s megablockbuster Keytruda rounded out the top four with $17.2 billion in revenue.

Novartis and Roche have struggled to commercialize COVID-19 therapies, although the latter has introduced a series of SARS-CoV-2 diagnostics. T…

Developing nations shun AstraZeneca’s COVID-19 vaccine

A number of developing nations have refused tens of millions of doses of AstraZeneca’s COVID-19 vaccines, according to a report from Reuters.

The countries had received doses of the AstraZeneca vaccine from the COVAX initiative, a global project that focuses on ensuring equitable access to COVID-19 vaccines.

COVAX has distributed 1.4 billion shots to 144 nations to date.

Some countries that COVAX serves indicated a preference for vaccines with a longer shelf life than AstraZeneca’s COVID-19 vaccine.

Last week, COVAX and the African Union also declined to order vaccine doses from Moderna, according to Reuters.

AstraZeneca’s COVID-19 Vaxzevria has a shelf life of six months, but doses are sometimes delivered weeks before the expiration date, Reuters reported.

In related news, Japan recently canceled a purchase of 40 million doses of the AstraZeneca vaccine, according to The Japan Times.

The country has expressed a preference for…

Dentsply CFO Jorge Gomez leaves to assume same role at Moderna

Moderna (Nasdaq:MRNA) announced today that it appointed Jorge Gomez as its new chief financial officer.

Gomez resigned as CFO of Dentsply Sirona (Nasdaq:XRAY), effective May 6, to assume the same role at Cambridge, Massachusetts-based Moderna. He will join effective May 9.

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

Dentsply CFO Jorge Gomez leaves to assume same role at Moderna

Moderna (Nasdaq:MRNA) announced today that it appointed Jorge Gomez as its new chief financial officer.

Gomez resigned as CFO of Dentsply Sirona (Nasdaq:XRAY), effective May 6, to assume the same role at Cambridge, Massachusetts-based Moderna. He will join effective May 9.

Dentsply Sirona said in a news release that it is initiating a search process to identify its next CFO.

“We thank Jorge for his many contributions since joining Dentsply Sirona in 2019, including strengthening the Finance and IT organizations and enhancing our ESG initiative,” Dentsply Sirona CEO Don Casey said in the release.

Gomez, who served as EVP and CFO at Dentsply since August 2019, spent 13 years at Cardinal Health with his most recent role there also being CFO.

“I am pleased to welcome Jorge to Moderna as our Chief Financial Officer and as a member of the Executive Committee,” Moderna CEO Stéphane Bancel said in a release. “As we grow and scale …

FDA backs second COVID-19 vaccine booster for some Americans

Image courtesy of Pixabay.

FDA has authorized a second booster dose of COVID-19 vaccine for individuals who are immunocompromised or 50 and over.

The expanded emergency use authorization applies to the vaccines from Pfizer (NYSE: Pfizer) and Moderna (Nasdaq: MRNA).

Individuals interested in obtaining a second booster dose must wait at least four months after receiving the first booster dose.

Immunocompromised individuals should have an equivalent level of immunocompromise to solid organ transplant recipients.

Immunocompromised patients at least 12 can receive the Pfizer vaccine. Conversely, the Moderna vaccine is available to those 18 and up.

To make the decision, the FDA reviewed real-world data from Israel, which indicated that an additional dose provides added protection against SARS-CoV-2 without causing unexpected side effects.

The Israeli data are from an ongoing, ope…

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…

Moderna seeks FDA blessing for second COVID-19 vaccine booster

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) recently asked FDA to allow individuals 65 and older to receive a second booster of their BNT162b2 COVID-19 vaccine.

Now, Moderna (Nasdaq:MRNA) is filing for FDA authorization to permit a fourth dose of its Spikevax (mRNA-1273) COVID-19 vaccine for adults 18 and older.

In its submission, Moderna included data gathered from the U.S. and Israel after the emergence of the omicron variant.

Data on the efficacy of a fourth dose of Moderna’s vaccine against omicron were recently published in NEJM. The researchers, considering data from the Moderna and Pfizer-BioNTech vaccines, concluded that a fourth dose of mRNA vaccine appears to be “immunogenic, safe, and somewhat efficacious (primarily against symptomatic disease).”

In January, early data from Israel’s Sheba Medical Center indicated that an additional booster of COVID-19 vaccine from Pfizer and BioNTech drove to a fivefold increase in antibodi…