Moderna Archives - Page 3 of 21 - Medical Design Sourcing

FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines in young children

Until recently, the Pfizer-BioNTech COVID-19 vaccine was available for all individuals 5 years of age and older, while the Moderna vaccine was authorized for individuals at least 18.

Now, the FDA has authorized the use of both vaccines in children from 6 months to four years old. In addition, the agency also agreed to allow the use of the Moderna vaccine in children aged 5 to 17.

“We know that many parents, caregivers and clinicians have been anxiously awaiting today’s authorizations,” said FDA Commissioner Dr. Robert M. Califf in a press briefing. “We’re acutely aware of the importance of having vaccines available for our youngest children. And as we’ve seen with the older age groups, we expect that the vaccines for younger children will provide protection for the most severe outcomes of COVID-19 such as hospitalization and death.”

Califf went on to stress that robust data support the use of safety and effective…

FDA advisors unanimously back Moderna and Pfizer COVID-19 vaccines in young children

An FDA panel voted 21 to 0 to authorize the Pfizer/BioNTech and Moderna COVID-19 vaccines in children between the ages of 6 months and 4 years of age.

Children under the age of 5 constitute the only age group that has not been eligible to be vaccinated against COVID-19.

“I know there are a lot of very relieved parents,” said Dr. Jon Portnoy, a voting member of the Vaccines and Related Biological Products Advisory (VRBPAC) panel. “I understand why parents are very nervous and fearful of doing normal activities, especially if their child actually catches COVID.”

The potential availability of two COVID-19 vaccines for young children “will certainly alleviate a lot of [parents’] concerns,” he added.

VRBPAC member Dr. Ofer Levy emphasized the importance of choice for parents with young children.

“They can partner with their pediatrician to make a decision,” Levy said. Vaccines are a vital tool for fighting COVID-19, especially in communiti…

FDA concludes Pfizer-BioNTech vaccine likely safe and effective in kids under 5

Pfizer-BioNTech

In the U.S., COVID-19 vaccines are widely available to all age groups apart from children under the age of five. However, that could change this month now that FDA has signaled that three doses of the Pfizer-BioNTech (NYSE:PFE/Nasdaq BNTX) COVID-19 vaccine are likely effective against COVID-19 in an analysis ahead of a June 15 Vaccines and Related Biological Products Advisory Committee meeting.

Pfizer and BioNTech, like Moderna (Nasdaq:MRNA), are seeking emergency use authorization (EUA) to use their respective vaccines in children aged six months to four years of age.

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

FDA concludes Pfizer-BioNTech vaccine likely safe and effective in kids under 5

In the U.S., COVID-19 vaccines are widely available to all age groups apart from children under the age of five. However, that could change this month now that FDA has signaled that three doses of the Pfizer-BioNTech (NYSE:PFE/Nasdaq BNTX) COVID-19 vaccine are likely effective against COVID-19 in an analysis ahead of a June 15 Vaccines and Related Biological Products Advisory Committee meeting.

Pfizer and BioNTech, like Moderna (Nasdaq:MRNA), are seeking emergency use authorization (EUA) to use their respective vaccines in children aged six months to four years of age.

Pfizer has provided FDA with new reactogenicity and immunogenicity data from the ongoing Phase 1/2/3 C4591007 trial.

In late May, Pfizer submitted a request to FDA to allow the use of three 3-μg doses of their BNT162b2 vaccine in the same demographic.

In April, Moderna announced that it had filed paperwork seeking EUA for two 25-μg doses of its mRNA-1273 vaccine in young children. Read more

Moderna’s first bivalent COVID-19 vaccine booster candidate shows promise

Moderna’s (NYSE:MRNA) bivalent booster COVID-19 vaccine candidate, mRNA-1273.211, bested its first-generation mRNA-1273 vaccine in a Phase 2/3 study.

The study compared the neutralizing antibody levels generated from both vaccine boosters. The mRNA-1273.211 vaccine booster candidate offered superior performance against all variants of concern, including omicron.

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

Moderna’s first bivalent COVID-19 vaccine booster candidate shows promise

Moderna’s (NYSE:MRNA) bivalent booster COVID-19 vaccine candidate, mRNA-1273.211, bested its first-generation mRNA-1273 vaccine in a Phase 2/3 study.

The study compared the neutralizing antibody levels generated from both vaccine boosters. The mRNA-1273.211 vaccine booster candidate offered superior performance against all variants of concern, including omicron.

The company notes that the mRNA-1273.211 booster outperformed the first-generation vaccine for six months.

In particular, the next-gen products led to a 2.20-fold boost in neutralizing antibody titers against omicron with the mRNA-1273.211 booster dose relative to the mRNA-1273 booster dose at 1 month. At 6 months, the new booster candidate led to a 2.15-fold increase in neutralizing antibody titers compared to the current booster.

mRNA-1273.211 is based on the beta variant, which shares some mutations with the omicron variant, whose subvariants continue to dominate the world.

Moderna’s new CFO leaves after former employer discloses investigation

Moderna (Nasdaq:MRNA) CFO Jorge Gomez is gone from his new job effective immediately, the COVID-19 vaccine maker said today.

Cambridge, Massachusetts–based Moderna said the departure comes after Gomez’s former employer, Dentsply Sirona (Nasdaq: XRAY), announced an “ongoing internal investigation into certain matters, including financial reporting,” Moderna said in a news release.

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

Moderna CFO steps down in first week on the job

COVID-19 vaccine maker Moderna (Nasdaq:MRNA) has announced that its chief financial officer (CFO) Jorge Gomez has resigned in his first week.

Gomez’s former employer Dentsply Sirona (Nasdaq: XRAY), announced an “ongoing internal investigation into certain matters, including financial reporting,” according to a Moderna news release.

Gomez will receive 12 months’ salary, amounting to $700,000. He will also give up his $500,000 signing bonus and bonus eligibility.

Cambridge, Massachusetts–based Moderna had announced its appointment of Gomez in April. He assumed the role on May 9.

Moderna’s former CFO, David Meline, will return to the role until the company finds a replacement.

Jorge Gomez

In April, the dental products company Dentsply Sirona fired its CEO, Don Casey, and removed him from its board. Case had assumed the CEO role in February 2018.

Dentsply Sirona recently disclo…

FDA signals careful approach in authorizing COVID-19 vaccines in young children

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

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

FDA signals careful approach in authorizing COVID-19 vaccines in young children

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

The agency has tentatively scheduled three VRBPAC meetings for June 8, 21 and 22 to discuss offering the Moderna and Pfizer-BioNTech vaccines to younger children.

In addition, the FDA will meet to discuss the possibility of recommending modifying the strain composition of COVID-19 vaccines for the fall.

The VRBPAC is scheduled to meet on June 7 to discuss authorization of the Novavax vaccine in adults 18 and older.

The Novavax NVX‑CoV2373 vaccine has received conditional authorization from several regulatory authorities internationally. Its pr…

Moderna names former Merck exec as new chief commercial officer

COVID-19 vaccine developer Moderna (Nasdaq:MRNA) has named Arpa Garay as its chief commercial officer starting May 31, 2022.

Garay worked more than 15 years at Merck & Co. (NYSE:MRK). In February, she was promoted to the post of chief marketing officer for Merck’s human health division. Garay also was a member of the company’s executive committee.

Arpa Garay

At Moderna, Garay will report directly to CEO Stéphane Bancel.

Garay has won several awards. She was named a G100 Next Gen Leader, Fortune named her as one of the “Most powerful Women: Next Gen” while Business Insider India and the Philadelphia Business Journal included her in rankings of leaders under 40.

“I am grateful and excited to work with an inspiring team and build a commercial organization to bring the transformative impact of Moderna’s mRNA science to improve lives around the world across many diseases,̶…

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.

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