Enlarge / Vials of the Pfizer COVID-19 vaccine. (credit: SOPA images )

With respiratory illnesses ravaging children around the US, vaccine partners Pfizer and BioNTech announced Monday that they are seeking regulatory authorization to offer their bivalent COVID-19 vaccine to children ages 6 months to 4 years—but not as a booster; instead it would be part of an updated primary series.

Currently, the bivalent vaccine, which targets the coronavirus omicron subvariants BA.4 and BA.5 in addition to an ancestral strain, is only available as a booster dose to Americans ages 5 years and up. Although BA.5 is no longer dominant in the US, its sublineages now reign. The Centers for Disease Control and Prevention recently published real-world effectiveness data indicating that the bivalent boosters increased protection against symptomatic COVID-19 infection over protection provided by the previous boosters.

For now, children under 5 only have had access to a primary series—two small doses of Moderna's original vaccine or three small doses of Pfizer/BioNTech's original vaccine. Both were first authorized on June 17 after a rollercoaster regulatory process that lasted months.

Enlarge / Pfizer CEO Albert Bourla talks during a press conference with the European Commission president after a visit to oversee the production of the Pfizer-BioNtech COVID-19 vaccine at the factory of US pharmaceutical company Pfizer, in Puurs, on April 23, 2021. (credit: Getty | John Thys )

Pfizer CEO Albert Bourla claimed at a news event last week that the company's COVID-19 vaccines will continue to be "free to all Americans," despite the company's plan to raise the price of the vaccine roughly 400 percent—a price difference that will be picked up by health insurers.

The company said in October that it plans to raise the price of a dose of its COVID-19 vaccine from about $30 to somewhere between $110 and $130 as it moves the shots to the commercial market next year.

Until now, all COVID-19 vaccines in the US have been bought by the US government, which paid $30.48 per dose in its latest vaccine supply agreement from June. The US government had previously paid $24 per dose in July 2021 and $19.50 per dose in July 2020. The government offered all the doses to Americans for free.

Enlarge (credit: Getty | Future Publishing )

The new bivalent COVID-19 booster spurred neutralizing antibody levels that were fourfold higher against the omicron subvariants BA.4/BA.5 in older adults than those seen after the original booster, Pfizer reported Friday .

The new data may help calm concerns about whether the updated booster is an improvement over the previous booster. But the fall booster campaign—aimed at preventing another devastating winter wave—still faces considerable challenges. For one thing, a shockingly low number of Americans are rolling up their sleeves to get the shot.

Better boost

Experts all agree that the new booster shot, like the old one, will revive waning immune responses to SARS-CoV-2 and provide strong protection from severe COVID-19. But some experts have expressed skepticism about whether the updated bivalent booster—which in part targets omicron subvariants BA.4/BA.5—will offer a clinically meaningful advantage over the previous booster in preventing mild infections against the subvariant.

Enlarge / An intensive care nurse cares for a patient suffering from respiratory syncytial virus (RSV), who is being ventilated in the children's intensive care unit of the Olga Hospital of the Stuttgart Clinic in Germany. (credit: Getty | picture alliance )

As an unusually large and early seasonal surge of RSV cases inundate children's hospitals around the country, pharmaceutical giant Pfizer offered a glimmer of hope Tuesday in the form of top-line, phase three clinical trial results.

The company's experimental RSV vaccine—given to pregnant trial participants—was 82 percent effective at preventing severe RSV-related lower respiratory tract illness in the first three months of an infant's life. It was 69 percent effective over the first six months, Pfizer announced.

“We are thrilled by these data as this is the first-ever investigational vaccine shown to help protect newborns against severe RSV-related respiratory illness immediately at birth,” Pfizer Chief Scientific Officer Annaliesa Anderson said in a statement.

Enlarge / Moderna states that it doesn't want to halt production or distribution of Pfizer/BioNTech's vaccine, but it does want to be paid a license for its claimed patents. (credit: Getty Images)

Now that the vaccine race is over and shots are broadly available, Moderna has filed suit against Pfizer and BioNTech, claiming they infringed on Moderna's mRNA patents from 2010-2016.

Moderna, a Massachusetts-based firm, filed suit against New York-based Pfizer and BioNTech in Düsseldorf, Germany, related to the firms' joint Comirnaty vaccine and its similarities to Moderna's Spikevax. Moderna claims in the suit that it doesn't want to halt vaccine production. The suit also doesn't seek damages for sales before March 8, 2022, sales in lower or middle-income AMC 92 nations, or sales where "the US Government would be responsible for any damages."

In a statement announcing the suit , Moderna stated that it expected Pfizer and BioNTech to "respect its intellectual property rights" and "consider a commercially reasonable license" to sell vaccines outside those accepted conditions, but the firms failed to do so.

Et c'est pas bien !

Z'êtes qu'une bande de sans-coeur, des Naineux !

Voilà ce que vous z'êtes !

Tsss...

#France, #Politique, #fr, #Covid, #Pfizer, #Bourla

Enlarge / Dr. Peter Marks, director of the Center for Biologics Evaluation and Research within the Food and Drug Administration, testifies during a Senate Health, Education, Labor, and Pensions Committee hearing on the federal coronavirus response on Capitol Hill on March 18, 2021, in Washington, DC. (credit: Getty | Pool )

On Thursday, the US Food and Drug Administration advised vaccine makers to reformulate COVID-19 booster shots for this fall. The boosters would target both the original strain of the pandemic coronavirus plus two new omicron subvariants—BA.4 and BA.5—which became the dominant versions of the virus circulating in the United States this week.

The FDA's announcement comes two days after its independent expert advisors voted overwhelmingly in favor of updating boosters to include an omicron component. The vote—19 in favor, two against—was simply in favor of including an omicron component generally. But, in their afternoon-long discussion, experts offered opinions that led to the FDA's more specific guidance.

Specifically, much of the committee expressed support for combination shots—aka bivalent boosters—that would target both the original virus and a version of omicron. There was also broad support for targeting the omicron subvariants BA.4 and BA.5 specifically, rather than earlier subvariants, such as the first, BA.1, which is no longer in circulation.

Enlarge / Boston Medical Center Child Life Specialist Karlie Bittrich sees to a baby while in a pediatrics tent set up outside of Boston Medical Center in Boston on April 29, 2020. (credit: Getty | Boston Globe )

A committee of experts advising the Food and Drug Administration voiced unanimous support Wednesday for the authorization of two COVID-19 vaccines for children under the age of 5. If the FDA authorizes the vaccines, it will mark the first time during the more than two-year pandemic that vaccines against COVID-19 will be available for this age group—the last group yet to be eligible for vaccination.

Although children in this young age group have a relatively lower risk of severe disease and death from COVID-19 compared with older groups, they can and do become severely ill and die from the infection. As of last month, 45,000 children under 5 have been hospitalized for COVID-19 during the pandemic; roughly 50 percent of those hospitalizations occurred during the omicron wave. Of the children who land in the hospital, about 63 percent have no underlying medical conditions that put them at greater risk of severe COVID-19. And about a quarter of those hospitalized require intensive care.

So far, 475 children under the age of 5 have died from COVID-19 during the pandemic, making COVID-19 far deadlier than other diseases we routinely vaccinate young children against, including influenza, measles, chickenpox, hepatitis A, and rotavirus.

ajrd hui auditionné sur les effets indésirables du vaccin anti #COVID19 " Le problème c pas le vax le prblm c'est l'obligation vax." #Pfizer

Bon... Le vaccin en lui-même est un putain de problème.

Son intervention complète est dans le Tweet en-dessous.

(Et je déteste l'écriture sms...)

#France, #Politique, #fr, #Vaccin, #Covid, #PassVaccinal, #CréditSocial