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

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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 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.

In particular, the agency recommends that vaccine makers develop bivalent COVID-19 vaccines with an omicron BA.4/5 spike protein component combined with the current vaccine composition.

FDA expects the updated vaccines to be used as a booster in “early to mid-fall 2022,” but the current formulation of vaccines for use as a primary series will remain unchanged.

Moderna and Pfizer have already shared data from c…

Pfizer seeks to comply with voluntary Net-Zero Standard by 2040

The voluntary Net-Zero Standard asks organizations to reduce emissions to near-zero levels by 2050 and neutralize any residual emissions.

Pfizer (NYSE:PFE) has announced its intent to meet that benchmark by 2040.

Pfizer intends to reduce its Greenhouse Gas (GHG) emissions by 95% and its value chain emissions by 90% from 2019 levels by 2040. To reach that goal, the company plans to reduce its reliance on fossil fuels and work with similarly-minded suppliers. It also plans to invest in a fleet of hybrid and electric vehicles.

The Net-Zero Standard was first announced by the Science-Based Targets initiative (SBTi).

Other pharma companies that have vowed to comply with the standard include AstraZeneca (LON:AZN), Bayer (OTCMKTS:BAYRY), Biogen (Nasdaq:BIIB), GSK (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Novartis (NYSE:NVS) and Sanofi (EPA:SAN).

Pfizer notes that its work to comply with the standard is part of its Environmental, Social and Gov…

Pfizer and BioNTech forge new COVID-19 vaccine deal with U.S. government

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) profited handsomely from COVID-19 vaccine sales in 2021. The firms raked in more than $59 billion in combined sales of the Comirnaty vaccine.

The two companies have now announced a new vaccine supply agreement with the U.S. government worth $3.2 billion. Under the terms of the agreement, the government will receive 105 million additional doses of the vaccine at the 30 µg, 10 µg and 3 µg dose levels.

The deal could include an omicron-adapted COVID-19 vaccine, assuming FDA authorizes an updated booster.

Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to back the use of omicron-containing boosters.

Pfizer announced that it could begin shipping doses for the deal as soon as the late summer and continue into the fourth quarter of 2022.

The U.S. government also has the option to buy up to 195 million additional doses for a total of 300…

Will COVID-19 vaccines be updated by fall?

Photo by Frank Meriño from Pexels

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.…