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Fall 2022 COVID-19 vaccine candidate tracker

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Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine.

But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus.

A variety of companies are developing next-generation COVID-19 vaccines that could potentially optimize the strength and durability of immune protection compared to the first crop of vaccines.

Here, we round up notable COVID-19 vaccine candidates that, at least, could help pave the way for the fall 2022 booster drive.

BNT162b5

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) are developing a bivalent COVID-19 vaccine candidate known as BNT162b5 based on the ancestral strain and a BA.1 Omicron variant. The vaccine has a modified spike protein design to optimize the immune response …

Pfizer and BioNTech complete European submission for omicron-adapted COVID vaccine

Pfizer and BioNTech today announced they submitted to the European Medicines Agency (EMA) for an omicron-adapted bivalent COVID-19 vaccine candidate based on the BA.1 sub-lineage.

The application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to develop an omicron-adapted bivalent vaccine candidate to address the spread of SARS-CoV-2.

Pfizer recently announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the omicron-adapted bivalent vaccine candidate had a superior immune response against omicron BA.1 as compared to its current COVID-19 vaccine. The bivalent vaccine candidate was well-tolerated with a favorable safety profile.

Pfizer and BioNTech previously shared the data with the FDA to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency.

Pfizer and BioNTech seek EMA authorization for COVID-19 vaccination in young children

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) have filed paperwork with the European Medicines Agency (EMA) requesting permission to use the Comirnaty COVID-19 vaccine in children aged 6 months to 5 years old.

As in the U.S., the companies are attempting to win authorization for a 3-µg dose vaccine administered as a three-dose series.

On June 17, FDA authorized the use of the Pfizer-BioNTech and Moderna vaccines in children as young as six months in the U.S. Before that, an FDA advisory committee unanimously supported the authorization of the Pfizer and Moderna vaccines in young children.

The EMA request included data from a Phase 2/3 randomized, controlled study based on data from 4,526 children 6 months to less than 5 years of age.

The study found that three doses of the vaccine resulted in a robust immune response with a safety profile similar to a placebo. In addition, the companies noted that adverse events were less common in young c…

CureVac files lawsuit against BioNTech over patent infringement

The mRNA-focused biopharma CureVac N.V. (Nasdaq:CVAC) has filed a lawsuit in the German Regional Court in Düsseldorf against BioNTech SE (Nasdaq:BNTX) demanding compensation for infringement of CureVac’s patents.

In particular, the lawsuit claims that the four German patents, EP 1 857 122 B1, DE 20 2015 009 961 U1, DE 20 2021 003 575 U1 and DE 20 2015 009 974 U1, were used in the manufacture of the Comirnaty COVID-19 vaccine from BioNTech and Pfizer (NYSE:PFE).

Investors reacted by sending CVAC shares down 1.05% to $14.09. Meanwhile, BNTX shares were up 2.24% to $161.03.

CureVac is not aiming to block the production or distribution of the COVID-19 vaccine.

Over the past year, CureVac has seen its stock valuation plummet after failing to commercialize its first-generation mRNA COVID-19 vaccine.

In June 2021, the company announced that the interim efficacy of the vaccine candidate was 47% in a Phase 2b/3 study.

CureVac is currently par…

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 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?

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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…

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 …

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…

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.

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