COVID-19 vaccine Archives - Page 2 of 38

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…

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…

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…

Valneva agrees to terminate UK supply agreement for COVID-19 vaccine

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has reached a settlement agreement with regulators in the United Kingdom related to the termination of a supply agreement for its COVID-19 vaccine candidate.

The company is attempting to salvage a COVID-19 vaccine deal with the EU after regulators announced plans to terminate an Advance Purchase Agreement (APA) related to the vaccine candidate.

VALN shares tumbled 6.87% to $15.73 in afternoon trading.

The company has developed the only whole virus, inactivated, adjuvanted vaccine candidate.

Demand for COVID-19 vaccines has faltered in recent months. The majority of the population in many European countries has been fully vaccinated.

On September 13, 2021, Valneva received a termination notice from the UK government.

The agreement between the parties included a provision giving the UK government the discretionary right to terminate for convenience.

The recent s…

Sanofi-GSK next-generation COVID-19 booster could go head-to-head against revised Moderna and Pfizer offerings

Sanofi (Nasdaq:SNY) and GSK (NYSE:GSK) have announced that their next-generation COVID-19 booster vaccine candidate based on the beta variant yielded a substantial immune boost in adults previously primed with mRNA vaccines.

The novel vaccine yielded a strong increase in antibody titers above baseline against various variants of concern, including a 40-fold increase against the BA.1 omicron subvariant 15 days after vaccination. The same vaccine also yielded a 15-fold increase against the original D614 virus and a 30-fold increase against the beta strain.

The results were from two studies, the VAT02 Cohort 2 and COVIBOOST VAT013.

The new vaccine candidate elicited a more robust immune response than the Pfizer-BioNTech booster vaccine or the first-generation Sanofi-GSK vaccine candidate.

Last week, Moderna (Nasdaq:MRNA) also announced that its bivalent omicron booster vaccine candidate, mRNA-1273.214 yielded 1.75 times more neutralizing antibodies t…

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

Valneva aims to salvage COVID-19 vaccine deal with EU

French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) is hoping to change the European Commission’s (EC) mind after regulators notified the firm that they intend to terminate an Advance Purchase Agreement (APA) for its inactivated whole-virus COVID-19 vaccine candidate VLA2001.

VALN shares fell 15% to $20.00.

In February, Valneva announced that it expected authorization for the vaccine in the European Union in April. Regulators from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had sent the company several questions about the vaccine candidate. Valneva said then that it swiftly answered them.

EMA accepted the filing of the Marketing Authorization Application on May 19.

After the European Commission received Valneva’s remediation plan, Valneva hopes to have further discussions with regulators interested in its inactivated, adjuvanted whole-virus vaccine.

Valneva ind…

FDA considers possible myocarditis link in Novavax COVID-19 vaccine recipients

In reviewing clinical trial data related to the Novavax (Nasdaq:NVAX) COVID-19 vaccine, FDA expressed concerns about the product’s potential to cause myocarditis, a type of heart inflammation.

In a briefing document, FDA noted that the “identification of multiple potential vaccine-associated cases in a premarket safety database of ~40,000 vaccine recipients raises concern.” The agency goes on to say that if causally associated, “the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorization use of mRNA COVID-19 vaccines (for which no cases were identified in pre-authorization evaluation).”

In a statement, Novavax concluded that the rate of myocarditis and a similar condition known as pericarditis was similar across vaccine and placebo recipients. In the vaccine arm, 0.007% experienced such heart inflammation, while 0.005% of placebo recipients did.

Myocarditis is a risk occasionally ass…

FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11

Pfizer-BioNTech

The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine.

The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said FDA Commissioner Robert M. Califf in a news release.

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

FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11

The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine.

The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said FDA Commissioner Robert M. Califf in a news release.

While “COVID-19 tends to be less severe in children than adults,” Califf noted that the omicron wave has resulted in more children getting infected and hospitalized with COVID-19 infections. “Children may also experience longer-term effects, even following initially mild disease,” he added.

The FDA has determined that vaccine effectiveness in all authorized populations wanes in the weeks and months following administration of a second dose.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID…