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Will COVID-19 vaccines be updated by fall?

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FDA advisors are slated to meet to discuss the prospect of updating the first generation of COVID-19 vaccines for use as boosters this fall and winter.

But it remains unclear whether updating the COVID-19 vaccines will be necessary. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) have updated vaccines in the works.

Pfizer and Moderna have both said their next-generation vaccines appear to be more effective against the omicron BA.1 variant. But fighting the growing number of omicron lineages could prove challenging. For example, the recent emergence of BA.4 and BA.5 subvariants threatens those infected with older omicron variants.

Pfizer noted in a press release that it was developing monovalent and bivalent versions of its COVID-19 vaccine, developed jointly with BioNTech. Protection appeared to be substantially stronger against the BA.1 subvariant than the BA…

Medtronic appoints Pfizer EVP as independent board director

Lidia Fonseca is EVP and chief digital and technology officer at Pfizer [Image courtesy of Fonseca]

Medtronic (NYSE:MDT) announced today that it appointed Lidia Fonseca to its board of directors as an independent director.

Fonseca, who serves as EVP and chief digital and technology officer at Pfizer, will become a director effective today. She will serve on the board’s Compensation Committee and Science and Technology Committee.

Get the full story on our sister site MassDevice.

Sanofi-GSK COVID-19 vaccine effective against omicron

GSK plc (LSE/NYSE:GSK) and Sanofi (NYSE:GSK) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study.

For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron.

The vaccine is based on the original D614 virus and the beta (B.1.351) strain.

Across variants, the vaccine was 64.7% efficacious against symptomatic infection in adults. For those previously infected with COVID-19, the vaccine was 75.1% efficacious overall.

GSK and Sanofi noted that the vaccine candidate appeared to be well-tolerated.

Moderna (Nasdaq:MRNA) is developing a bivalent omicron booster vaccine candidate known as mRNA-1273.214.

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) have released minimal data to date on their next-generation COVID-19 vaccine.

Sanofi’s and GSK’s Phase 3 COVID-19 clinical trial, dubbed VAT08, enrolled more …

Pfizer invests $95 million in vaccine firm Valneva

After struggling to find support for its inactivated whole-virus COVID-19 vaccine candidate VLA2001, French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has received a €90.5 ($95) million investment from Pfizer (NYSE:PFE), which amounts to 8.1% of the company’s share capital at a price of €9.49 per share.

The Saint-Herblain, France–based company plans on using the funding to support a planned Phase 3 study involving the Lyme disease vaccine candidate VLA15. Pfizer will lead the Phase 3 study, scheduling it for the third quarter of 2022.

In February, Valneva and Pfizer announced positive data from a Phase 2 study of the VLA15 vaccine. The data suggested that a three-dose primary series of the vaccine promised to offer a robust immune response.

In related news, the European Medicines Agency recently recommended authorizing Valneva’s VLA2001 COVID-19 vaccine for individuals between 18 and 50.

After the vaccine won regulatory approval …

Young children in U.S. now eligible for COVID-19 vaccination

Some 18 months after adults became eligible for COVID-19 vaccines, children between 6 months to 4 years old can now be vaccinated in the U.S.

FDA authorized the shots for young children on June 17, while CDC did so a day later.

“The United States is now the first country in the world to offer safe and effective COVID-19 vaccines for children as young as six months old,” said President Joe Biden in a press briefing. “And for the first time in our fight against this pandemic, nearly every American can now have access to life-saving vaccines.”

Biden noted that the U.S. government had ample supplies of vaccines for young children and had coordinated with states, local health centers, pharmacies and pediatricians to help administer the shots.

“My administration, with the help of the CDC, has been planning and preparing for this moment for a long time,” Biden said.

The federal government has also created a webs…

EMA begins rolling review of Moderna’s and Pfizer’s updated COVID-19 vaccines

European Medicines Agency (EMA) has begun a rolling review for updated versions of Moderna’s and Pfizer/BioNTech’s vaccines modified to optimize protection against newer variants of SARS-CoV-2.

Earlier this month, Moderna (Nasdaq:MRNA) announced that its Omicron-containing bivalent COVID-19 booster candidate, mRNA-1273.21, provided an antibody response that was statistically superior to the original version of the vaccine, mRNA-1273.

EMA has also begun a rolling review of an updated version of the COVID-19 vaccine from Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX).

EMA’s review will first focus on data from laboratory studies in addition to chemistry, manufacturing and controls (CMC) data associated with the manufacture of the vaccines.

The vaccine developers will ultimately provide EMA with more information as part of the rolling review process.

While mRNA-1273.21 is Moderna’s lead candidate for t…

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…

Pfizer gears up for Paxlovid new drug application submission to FDA

The most popular COVID-19 antiviral is Paxlovid (nirmatrelvir [PF-07321332] and ritonavir). The manufacturer of the drug, Pfizer Inc. (NYSE: PFE), anticipates selling about $22 billion worth of Paxlovid this year.

Complicating matters, however, is the failure of the drug to meet its primary endpoint of self-reported, sustained alleviation of all COVID-19 symptoms for four consecutive days in the EPIC-SR study.

In a press release describing the gathering of new data to support a new drug application submission, Pfizer noted that EPIC-SR data from standard-risk vaccinated and unvaccinated patients were not statistically significant but underscored its efficacy overall.

In the EPIC-SR study, the drug passed the statistically significant threshold of reducing COVID-19-related medical visits per day compared to placebo by 62%. In addition, the study found a non-significant 70% relative risk reduction for the key secondary endpoint of hospitalization or death.…

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

Pfizer completes ReViral acquisition

Pfizer (NYSE:PFE) announced today that it completed its previously announced $525 million acquisition of ReViral.

ReViral, a biopharmaceutical company, discovers, develops and commercializes novel antiviral therapeutics designed to target respiratory syncytial virus (RSV). Its portfolio includes the sisunatovir oral inhibitor for blocking the fusion of the RSV virus to the host cell. Sisunatovir has fast track designation from the FDA.

Sisunatovir proved effective in significantly reducing viral load in a phase 2 RSV human challenge study in healthy adults. ReViral currently has a phase 2 clinical development in infants underway, as well as a second program focused on the inhibition of RSV replication, targeting the viral N protein, in phase 1 clinical development.

Pfizer announced in April that it agreed to acquire ReViral for up to $525 million, including upfront and development milestones. The company believes annual revenue for programs related to th…