Bivalent vaccine

2022 - 10 - 12

Coronavirus (COVID-19) Update: FDA Authorizes Moderna and ... (FDA.gov)

The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to ...

- For the 6 years through 11 years age group, the authorization is also based on the effectiveness of a single booster dose of the monovalent Moderna COVID-19 Vaccine in this age group. - For the 12 through 17 years age group, the authorization is also based on the effectiveness of a single booster dose of the monovalent Moderna COVID-19 Vaccine in this age group. The most commonly reported side effects after a booster dose of the monovalent Moderna COVID-19 Vaccine in the clinical trial participants for both age groups were pain, redness and swelling at the injection site, tiredness, headache, muscle pain, chills, joint pain, underarm swollen lymph nodes in the same arm as the injection, nausea/vomiting and fever. For each of the bivalent COVID-19 vaccines authorized today, the FDA relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. In addition, the authorization is based on the With today’s authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. The immune response to the booster dose of Moderna COVID-19 Vaccine in the 12 through 17 years age group was comparable to the immune response to the two-dose primary series in the adult participants. These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized.

Omicron boosters for kids 5-12 are cleared by the CDC (NPR)

Tweaked boosters rolled out for Americans 12 and older last month, modified to target today's most common and contagious variant. The latest move may expand ...

For the updated booster made by Pfizer and its partner BioNTech, 5- to 11-year-olds would get a third of the dose that anyone 12 and older already receives. The updated boosters are "extremely important" for keeping kids healthy and in school, said Dr. Only people who've gotten their initial vaccinations — with any of the original-formula versions — qualify for an updated booster. That's partly because both companies already had studied experimental shots tweaked to target prior COVID-19 variants, including an earlier omicron version, and found they safely revved up virus-fighting antibodies. As of last weekend, only at least 13 million had gotten an updated booster, White House COVID-19 coordinator Dr. He hopes the updated shots will "re-energize interest in protecting children for the winter."

Pfizer and BioNTech Receive U.S. FDA Emergency Use ... (Pfizer)

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years ...

This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including an EUA in the U.S. [www.pfizer.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizer.com&esheet=52942220&newsitemid=20221011006028&lan=en-US&anchor=www.pfizer.com&index=14&md5=0c32cea7d53c6f974a652712ce9b181d). Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties. [www.vaers.hhs.gov/reportevent.html](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.vaers.hhs.gov%2Freportevent.html&esheet=52942220&newsitemid=20221011006028&lan=en-US&anchor=www.vaers.hhs.gov%2Freportevent.html&index=3&md5=77e06406b5d1d6eb24f468eec48ab6a0). The information contained in this release is as of October 12, 2022. at [www.pfizersafetyreporting.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.pfizersafetyreporting.com&esheet=52942220&newsitemid=20221011006028&lan=en-US&anchor=www.pfizersafetyreporting.com&index=4&md5=3b5e6b76288f17d8a465927ff0c12d62)or by calling 1-800-438-1985 - Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY® (COVID-19 vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. Additionally, pre-clinical data showed a booster dose of the 30-µg BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus. These may not be all the possible side effects of the vaccine.

What Manitoba is saying about the availability of the Pfizer bivalent ... (CTV News)

The Manitoba government said residents should 'stay tuned' to find out when the Pfizer bivalent will be coming to Manitoba.

The closures reflect conservation concerns about both crab species following bleak summer populations surveys. Capital Regional District workers who are part of a local union voted overwhelmingly in favour of potential strike action as contract negotiations continue with the CRD. [Vancouver](https://bc.ctvnews.ca/) [Amanda Todd case: Defence seeks six-year sentence for Dutch man convicted of extorting, harassing B.C. Quebec Premier Francois Legault will announce a new cabinet on Thursday, October 20 at 2 p.m. Quebec public health officials held a COVID-19 news conference Wednesday, urging people to stay up-to-date on their vaccines. 11, seizing a loaded gun and illegal drugs. Here is how the new program works. CTVNews.ca speaks with a stargazing expert on how best to see the planet-moon pairing. CTVNews.ca breaks down everything you need to know. B.C.’s provincial health officer and its health minister said the province is set to receive 1.7 million doses. It is also suggested that individuals wait six months from their last COVID-19 vaccine before they receive a booster dose. Manitobans need to complete their primary vaccine series before they can get a bivalent vaccine booster.

U.S. authorizes updated COVID booster shots for children as young ... (Reuters)

The U.S. Food and Drug Administration on Wednesday green-lighted Moderna's bivalent vaccine for those aged six and above, while Pfizer's updated shot was ...

The U.S. The BA.5 subvariant of Omicron currently remains the dominant strain, accounting for nearly 79% of the cases in the United States. Register now for FREE unlimited access to Reuters.com Pfizer said it has the capacity to ship up to 6 million pediatric doses in the first seven calendar days, without any impact to distribution output of the doses for individuals aged 12 years and older. Centers for Disease Control and Prevention also backed the FDA's authorization, clearing the way for the shots to be administered in children. [(MRNA.O)](https://www.reuters.com/companies/MRNA.O) and Pfizer Inc [(PFE.N)](https://www.reuters.com/companies/PFE.N) in children as young as 5, a move that will expand the government's fall vaccination campaign.

Coronavirus Disease 2019 (CDC)

This follows the Food and Drug Administration's (FDA) authorization of updated COVID-19 vaccines from Pfizer-BioNTech for children ages 5 through 11 years, and ...

This follows the Food and Drug Administration’s (FDA) authorization of updated COVID-19 vaccines from Pfizer-BioNTech for children ages 5 through 11 years, and from Moderna for children and adolescents ages 6 through 17 years. Walensky, M.D., M.P.H., signed a decision memo expanding the use of updated (bivalent) COVID-19 vaccines to children ages 5 through 11 years. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.

FDA authorizes bivalent COVID-19 boosters for children ages 5 to 11 (USA TODAY)

Children ages 5 to 11 can now get a COVID booster after the FDA authorized the bivalent dose Wednesday from both Pfizer-BioNTech and Moderna.

The FDA decided the change to a bivalent vaccine is not likely to have a different effect or risk profile than the earlier shots. It is essential that children remain up-to-date with their COVID-19 vaccinations for their own health and potentially to protect more vulnerable adults around them, especially as we head towards a potential surge of cases this winter,” said Dr. It's not clear when or whether the booster will become available for even younger children. The Moderna booster dose for children ages 6 to 11 is 25 micrograms. The Pfizer-BioNTech and Moderna boosters are considered equivalent, with no proven difference in terms of effectiveness or side effects for either one or for mixing vaccines. The Masimo Foundation does not provide editorial input. [now account for about 80% of the variants](https://covid.cdc.gov/covid-data-tracker/#variant-proportions) seen in the United States, a figure that has fallen in recent weeks. “As a pediatrician, this is welcome news. The companies have not yet completed clinical trials of the booster in younger children. “We encourage parents to consider primary vaccination for children and follow up with an updated booster dose when eligible.” Adults are told to wait three months after an infection before getting a booster. If Americans did that, we could save hundreds of lives each day this winter."

FDA Authorizes Bivalent COVID-19 Booster Shots For Kids Over Age 5 (Healthline)

FDA Authorizes Bivalent COVID-19 Booster Shots For Kids Over Age 5 · The FDA has authorized new COVID-19 bivalent boosters for children as young as 5. · The new ...

“This is something that is pretty useful as we head into the fall and winter months, when people are more likely to gather indoors.” The more recently emerged [BA.4.6](https://www.gavi.org/vaccineswork/another-new-covid-variant-spreading-heres-what-we-know-about-omicron-ba46), which appears to be better able to evade our immune response than BA.5, accounts for 13.6% in the country. This vaccine target is the spike protein of the coronavirus, which the virus uses to infect cells. “So we continue to monitor the vaccines in real time after they are authorized.” However, “even though it’s reasonable to think this, we really don’t know if it will actually do that.” This prior immunity may affect a person’s response to vaccination with an updated booster. In addition, “there’s nothing dramatically new that’s in the [BA.4/5 bivalent] vaccine, other than that they’ve changed what it’s targeting,” said Sobhanie. Unless vaccine makers use new technology to produce the flu vaccines, no additional clinical trials are needed. As of Oct. Since the FDA’s initial authorization of the bivalent vaccines, several new coronavirus subvariants have emerged around the world. Ashish Jha, head of the White House COVID task force, said Oct. This includes animal studies on the BA.4/5 boosters, clinical trials of bivalent BA.1 boosters, clinical trials of the original vaccines and boosters, and ongoing monitoring of the safety of the current vaccines.

Bivalent vaccine

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