Vaccinations News : fda covid vaccine children + 4th covid vaccine

Vaccinations for Younger Children Could Start in Days

A C.D.C. panel is expected to recommend shots for 5- to 11-year-olds. The Biden administration has enlisted 20,000 health workers and shipped 15 million doses ahead of the decision.

Is the Pfizer-BioNTech coronavirus vaccine safe for children ages 5 to 11? Does it work? Does every child need it?

The Food and Drug Administration on Friday authorized the vaccine for emergency use in those age groups, following a near-unanimous recommendation from its advisers last week. On Tuesday, a similar committee advising the Centers for Disease Control and Prevention will have its say. (The meeting is scheduled to begin at 11 a.m. Eastern time and will be streaming here.)

If, as expected, the advisers recommend the vaccine and the agency’s director, Dr. Rochelle Walensky, signs off, the decision would most likely ease the worries of millions of parents and buttress the United States’ defenses against the virus before winter arrives.

Inoculations for children ages 5 through 11 could then begin this week. Anticipating the agency’s decision, the Biden administration has enlisted more than 20,000 pediatricians, family doctors and pharmacies to administer the vaccines.

About 15 million doses are already being packed with dry ice, loaded into small specialized containers and shipped via airplanes and trucks to vaccination sites across the country, federal officials said on Monday.

The younger children will receive one-third of the dose authorized for those 12 and older, delivered by smaller needles and stored in smaller vials to avoid a mix-up with adult doses.

The C.D.C.’s guidelines for the vaccine’s use are not legally binding, but heavily influence the medical community’s practice. An endorsement would be timely, as Americans begin to plan for the winter holidays.

Covid-19 vaccine for kids: Live updates on the CDC meeting

CDC adviser predicts “vote will be overwhelmingly in favor” to recommend Pfizer’s Covid-19 vaccine for kids

The US Centers for Disease Control and Prevention’s vaccine advisers, the Advisory Committee on Immunization Practices, is schedule to vote Tuesday whether to recommend Pfizer’s Covid-19 vaccine for children ages 5 to 11. It’s the last step before CDC Director Dr. Rochelle Walensky will make a final decision on the vaccine.

In the meeting that will run from 11 a.m. to 5 p.m. ET, Pfizer will present its data to the advisers in the morning. In the afternoon, the committee will hear from the CDC, which will discuss the overall need young children have for this vaccine, as well as any potential side effects.

One side effect under discussion is the risk of myocarditis – an inflammatory heart condition. It’s rare but has been seen in some adolescents and adults who got the Pfizer/BioNTech and Moderna vaccines.

Dr. Grace Lee, the chair of the committee, told CNN while data is limited, the surveillance systems in place are doing a good job picking up on vaccine safety signals. She said the CDC is also doing a long-term study of people who develop myocarditis after vaccination.

The Supreme Court Allowed a Key Aspect of Vaccine Mandates to Stand. That May Not Last Forever.

On Friday, the Supreme Court declined to intervene in a vaccine mandate in Maine that applies to all healthcare workers, even if they object to the mandate for religious reasons. But while the court did not act in this case, the positions of several justices put on the table the possibility that in the future they might overturn a mandate without a religious exemption.

Most states allow religious exemptions to vaccine mandates in one form or another. These exemptions generally allow individuals to avoid complying on First Amendment grounds. Maine’s rule had no such exemption, and several healthcare workers appealed to the courts for emergency relief, meaning that the court did not hear the full arguments for or against it. The Supreme Court allowed the Maine rule to stand, but three justices posted a strong dissent suggesting that they would have put the mandate on hold. Two others refused the stay simply because the case was requesting emergency relief.

It is well in line with previous Supreme Court precedent—including from the past year—to uphold a vaccine mandate without a religious exemption as compatible with the First Amendment. It’s also the right thing on policy grounds. Two characteristics of vaccine mandates work against requiring religious exemptions: First, they are safety rules, designed to prevent physical harm and save lives. Second, many requests for religious exemptions come from people whose real opposition to vaccines is not religious. In light of these two elements, the Supreme Court should not require religious exemptions.

4th covid vaccine

CDC: Immunocompromised May Need 4th COVID Shot

Some people with moderately or severely compromised immune systems may need a fourth dose of mRNA COVID-19 vaccine six months after a third shot, the U.S. Centers for Disease Control and Protection said this week in updated guidance.

It was only last August that the CDC authorized a third dose of vaccine for moderately and severely immunocompromised people, noting that they may not develop a full immune response from just two doses. Immunocompromised people who are fully vaccinated make up “a large proportion” of breakthrough cases needing hospitalization, the CDC says.

“Moderately and severely immunocompromised people aged ≥18 years who completed an mRNA COVID-19 vaccine primary series and received an additional mRNA vaccine dose may receive a single COVID-19 booster dose (Pfizer-BioNTech, Moderna, or Janssen) at least 6 months after completing their third mRNA vaccine dose,” the CDC said in its updated guidance. “In such situations, people who are moderately and severely immunocompromised may receive a total of four COVID-19 vaccine doses.”

The CDC is not making a recommendation on a fourth “additional” dose — which differs from a booster shot — but urges people to discuss the possibility with their health care providers.

The CDC says severely or moderately immunocompromised people make up about 3% of the U.S. population. Falling under that definition are people receiving active cancer treatment for tumors or cancers of the blood, diagnosed with advanced or untreated HIV infection, undergoing active treatment with high-dose corticosteroids or other drugs that may suppress the immune response, and organ transplant and stem cell recipients.

The fourth-dose guidance doesn’t apply to people who received the Johnson & Johnson vaccine, which doesn’t use mRNA technology. Immunocompromised people who got the one-shot J&J vaccine should get a second shot of any approved vaccine at least two months after the first shot, the CDC says.

The CDC differentiates between “additional” shots and “booster” shots.

“An additional dose is administered to people with moderately to severely compromised immune systems,” the CDC says. “This additional dose of an mRNA COVID-19 vaccine is intended to improve immunocompromised people’s response to their initial vaccine series. A booster shot is administered when a person has completed their vaccine series, and protection against the virus has decreased over time.”

The CDC does not recommend immunocompromised people receive an additional dose plus a booster shot.

Will there be a 4th COVID-19 booster shot for immunocompromised?

The CDC is updating its recommendations this week to say that the seriously immunocompromised can get a fourth booster shot 6 months after their third dose of the COVID-19 vaccine.

Can I get Pfizer booster after Moderna vaccine?

The U.S. Food and Drug Administration said Wednesday that people can get boosters that are different from the vaccine they originally received. So if you got Pfizer six months ago, you could get a booster from Moderna or Johnson & Johnson, as long as you are eligible otherwise.

Can you still get COVID-19 after vaccine?

Most people who get COVID-19 are unvaccinated. However, since vaccines are not 100% effective at preventing infection, some people who are fully vaccinated will still get COVID-19. An infection of a fully vaccinated person is referred to as a “breakthrough infection.”

How are COVID vaccines working in the immunocompromised?

fda covid vaccine children

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.

Key points for parents and caregivers:

Effectiveness: Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In addition, the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 through 11.
Safety: The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said Acting FDA Commissioner Janet Woodcock, M.D. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).

In the U.S., COVID-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age. According to the CDC, approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization. As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in the 5 through 11 years age group.

nyfd vaccine mandate

De Blasio slams FDNY firefighters for faking sick over vaccine mandate, vows consequences

Mayor de Blasio on Monday attacked city firefighters for feigning illness to protest vaccination mandates — and promised consequences for those who don’t report to their jobs.

De Blasio employed the threatening rhetoric on the first day that city employees who’ve refused to get the vaccination can be docked pay for doing so. As of Monday morning, he said a total of 9,000 city workers are on leave without pay, or about 6% of the entire city workforce, which is approximately 378,000 strong.

But on Monday, he seemed to single out firefighters who are now being accused of faking sick to take time off.

“We have every reason to believe that there’s a lot of people out there claiming to be sick who are not. It’s not acceptable,” he said at his Monday morning news briefing. “The thing to do is to do the right thing. Come to work. Protect people — as you took an oath to do.”

2,300 NYC firefighters call out sick as vaccine mandate begins, but mayor says public safety not disrupted

Hundreds of New York City firefighters called in sick Monday morning as the Covid-19 vaccine mandate for municipal employees went into effect, bringing the total number of sickouts in the fire department to 2,300, FDNY Commissioner Daniel A. Nigro said at a news conference.
Normally, 800-1,000 fire department employees call in sick on any given day, FDNY spokesperson Jim Long told CNN.
Nigro said many people calling in sick were protesting the vaccine mandate.

“If you’re sick, you’re sick, it’s a dangerous job. I get it. If you’re not sick, I want to see you back at work,” Nigro said.

“Once the members come to their senses and stop using medical leave improperly, they can help out not only the citizens of the city but their brothers and sisters who are staffing these units,” Nigro said.

Are immunocompromised individuals more vulnerable to COVID-19?

People who are immunocompromised in a manner similar to those who have undergone solid organ transplantation have a reduced ability to fight infections and other diseases, and they are especially vulnerable to infections, including COVID-19.

Can immunocompromised people get the COVID-19 vaccine?

People with immunocompromising conditions or people who take immunosuppressive medications or therapies are at increased risk for severe COVID-19 illness. The currently FDA-approved or FDA-authorized COVID-19 vaccines are not live vaccines and therefore can be safely administered to immunocompromised people.

When is a immunocompromised person fully vaccinated for COVID-19?

For public health purposes, immunocompromised people who have completed a primary vaccine series (i.e., 2-dose mRNA vaccine series [Pfizer-BioNTech and Moderna] or single dose of the Janssen vaccine) are considered fully vaccinated ≥2 weeks after completion of the series.