Moderna says Pfizer-BioNTech COVID vaccine infringed its patents

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer and its COVID-19 vaccine partner BioNTech over patent infringement in U.S. and German courts.

Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany.

The suits could pit three of the most significant COVID-19 vaccine makers against each other in an IP battle with billions of dollars potentially at stake. COVID-19 vaccine revenue boosted Pfizer to the top of the list among the Pharma 50 largest pharmaceutical companies on Drug Discovery & Development. Moderna and BioNTech also joined the Pharma 50 for the first time in the most recent edition.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” Moderna CEO…

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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…

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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.

The request breaks young children into two groups, with the first covering the ages of 6 months to under 2 years and the second covering kids between 2 and 5 years old. The authorization request refers to a primary series consisting of two 25-μg doses of mRNA-1273.

Moderna also seeks similar authorizations for young children from other international regulatory bodies.

The company is basing the requests on positive interim data from the Phase 2/3 KidCOVE study, which met its primary endpoint.

The study analyzed…

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100-µg booster dose of Moderna’s vaccine increases antibody levels 83 times against Omicron

Moderna (NSDQ:MRNA) is touting preliminary data suggesting that its COVID-19 vaccine booster led to robust antibody increases against the Omicron variant, both at the 50 µg and 100 µg dose levels.

The 50 µg booster dose, which is currently authorized under emergency use authorization, led to a 37-fold increase compared to pre-boost levels 29 days post-boost. A 100 µg booster dose led to an 83-fold increase in the same time window.

The National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center and Duke University Medical Center conducted the research on sera from 20 booster recipients for the mRNA-1273 vaccine at both 50 µg and 100 µg dose levels.

Two doses of the Moderna vaccine, however, did not offer robust protection against Omicron.

Moderna, like Pfizer, is also developing an Omicron-specific vaccine. Moderna’s is known as mRNA-1273.529.

Moderna anticipates to organize clinical trials for the Omicron-based va…

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Moderna to expand its Massachusetts manufacturing capabilities 

Cambridge, Mass.–headquartered Moderna (NSDQ:MRNA) will hire at least 155 new manufacturing employees for manufacturing jobs at its plant in Norwood, Mass.

A $2.33 million tax incentive from the Massachusetts Life Sciences Center helped bankroll the expansion. The investment will enable the company to double the size of its manufacturing site in Norwood, Mass., which became operational in 2018.

With limited manufacturing capability, Moderna has had to rely on partners with contract manufacturers such as Lonza(SWX:LONN), Catalent (NYSE: CTLT), Baxter BioPharma Solutions (NYSE: BAX), Recipharm and Laboratorios Farmacéuticos Rovi (BME:ROVI).

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

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Moderna’s COVID-19 vaccine 100% effective in teens

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) has joined Pfizer (NYSE:PFE) in announcing that its vaccine was 100% effective in a Phase 2/3 study involving adolescents. It will seek regulatory authorization to expand the use of its vaccine to adolescents as young as 12 in early June.

In the TeenCOVE study, no participants who received two doses of the mRNA-1273 vaccine contracted symptomatic COVID-19.

Using a secondary CDC case definition of COVID-19 that includes milder illness, the trial found that the vaccine was 93% effective in seronegative participants. The secondary case definition requires the presence of one COVID-19 symptom and a positive reverse transcription-polymerase chain reaction (RT-PCR) test. The company used that definition because COVID-19 transmission in adolescents is lower than in adults.

Side effects in the trial were generally mild or moderate for v…

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39-year old Utah woman dies after getting second dose of COVID-19 vaccine

Image from Nataliya Vaitkevich via Pexels

Researchers have not found causal links between COVID-19 vaccination and deaths, but a handful of post-vaccine deaths are making headlines.

One such case is the death of Kassidi Kurrill, a 39-year-old resident of Ogden, Utah, who recently passed away four days after receiving the second dose of Moderna COVID-19 vaccine.

Before her death, Kurrill complained that her heart was racing and was later rushed to the emergency room. Doctors reported that “her liver was not functioning,” according to her father, Alfred Hawley, in an interview with Salt Lake City–based KUTV.

Kurrill died some 30 hours later.

She reported having no significant side effects from the first vaccine dose.

Her family is awaiting autopsy results.

A Miami physician died from immune thrombocytopenia in January after receiving a COVID-19 vaccine, but researchers have n…

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BREAKING: J&J’s Phase 3 COVID-19 vaccine study results raise more alarms about new variants

Johnson & Johnson (NYSE:JNJ) announced results from its COVID-19 vaccine trial that show decreased effectiveness against new virus variants.

The vaccine candidate from Johnson & Johnson’s Janssen Pharmaceutical Companies, which was 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination, proved less effective in South Africa, where a new variant of the virus has appeared, offering just 57% protection from moderate-to-severe infection there (where 95% of cases were due to infection from the variant). The level of protection in the U.S. was 72% and it was 66% in Latin America.

“These results are a testament to the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program, and we are extremely grateful to the clinical trial staff and trial participants for their invaluable contributions,” Janssen R&D global head Dr. Mathai Mamment said in a news release. “Changing the trajector…

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Moderna details ‘proactive’ strategy to fight emerging COVID-19 variants  

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

While the so-called ‘U.K. variant’ of COVID-19 has triggered alarm, it may be a harbinger of things to come, as the novel coronavirus mutates across the world, complicating mass-vaccination efforts. 

Moderna (NSDQ:MRNA) detailed its plans to combat the matter in a briefing with investors. While it expects two 100-µg doses of its mRNA-1273 vaccine to be effective against emerging strains of the virus, it fares less well against the South African variant, B.1.351. 

The so-called “Brazil variant,” also known as P.1, possesses about 20 mutations. Like the U.K. and South African variants, researchers believe the Brazilian variant to be more transmissible, but it may also be more likely to reinfect people.

“We have followed SARS-CoV-2 mutations since January 2020,” said Moderna CEO Stéphane Bancel in the briefing. The virus has mutated many times, and it…

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Moderna’s COVID-19 vaccine may not respond as well against South African variant

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) announced today that it will start a Phase 1 study in the U.S. of an emerging variant vaccine booster candidate against a new COVID-19 variant out of South Africa. The company will also test an additional booster of its present vaccine.

The Cambridge, Mass.–based company said it has observed a sixfold reduction in neutralizing antibodies that its COVID-19 vaccine is able to produce against the new South African variant, though it said it still expects the two-dose regimen of its vaccine to be protective against emerging strains detected to date.

The in vitro neutralization studies, which involved sera from individuals vaccinated with Moderna’s vaccine, found no significant reduction in neutralizing antibodies related to the variant that has emerged out of the U.K.

“As we seek to defeat the COVID-19 virus, which has created…

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