International [U.S COVID Vaccine News] CDC to Lift COVID-19 Testing Requirement for international Travelers

Foreign tourists with COVID-19 vaccines approved by FDA or WHO can enter the US in November
By Bailey Schulz | Oct 11, 2021



Foreign tourists vaccinated against COVID-19 with a drug approved by the U.S. Food and Drug Administration or World Health Organization will get the green light to enter the United States in November, according to a spokesperson from the Centers for Disease Control and Prevention.

"Earlier this week, to help them prepare their systems, we informed airlines that the vaccines that are FDA authorized/approved or listed for emergency use by WHO will meet the criteria for travel to the U.S.," CDC spokesperson Caitlin Shockey told USA TODAY.

The FDA has authorized three COVID-19 vaccines for emergency use during the pandemic: Moderna, Johnson & Johnson and Pfizer-BioNTech, the last of which has received the FDA's full stamp of approval. The WHOgranted approval for those three as well as the Oxford-AstraZeneca/Covishield, Sinopharm and Sinovac vaccines.

Shockey did not say how, or if, travelers who had received vaccines not approved by the WHO would be able to enter the U.S. for tourism purposes.

"CDC will release additional guidance and information as the travel requirements are finalized," she said in an emailed statement.

The U.S. announced on Sept. 20 it would be introducing a new international air travel system in "early November" that would open travel for vaccinated foreign nationals. The initial announcement did not say which vaccines would be accepted, although health officials had previously told USA TODAY the CDC would likely allow those approved by the WHO.

What are the entry requirements for foreign travelers?

Foreign travelers will need to show proof of full vaccination prior to boarding U.S.-bound planes. A COVID-19 test will also be required within three days of departure and proof of negative results must be shown. Enhanced contact tracing and masking will also be required, but there will be no quarantine mandate.

https://www.usatoday.com/story/trav...ed-vaccines-enter-us-november-cdc/6059419001/
 
Last edited:
Vaccinated Canadians who got two different doses in those early vaccine-shortage days can come as well. :)

U.S. will accept mixed doses of vaccines from international travelers

By David Shepardson | October 15, 2021



WASHINGTON, Oct 15 (Reuters) - The U.S. Centers for Disease Control and Prevention (CDC) said late on Friday that it will accept mixed-dose coronavirus vaccines from international travelers, a boost to travelers from Canada and other places.

The CDC said last week that it would accept any vaccine authorized for use by U.S. regulators or the World Health Organization. "While CDC has not recommended mixing types of vaccine in a primary series, we recognize that this is increasingly common in other countries so should be accepted for the interpretation of vaccine records," a CDC spokeswoman said.

The White House said Friday the new vaccine requirements for foreign nationals traveling to the United States will begin Nov. 8 for visitors crossing at land borders as well as international air travelers.

Representative Brian Higgins, a New York Democrat representing a district along the Canadian border, had on Friday asked the CDC if it would accept the mixed vaccine doses noting "nearly four million Canadians, equivalent to 10% of their fully vaccinated population, have received mixed doses of the available mRNA COVID-19 vaccines – this includes the AstraZeneca vaccine."

The CDC said the vaccines approved by the Food and Drug Administration (FDA) for use, as well as those authorized by the WHO, will be accepted for entry into the United States, including the AstraZeneca (AZN.L) vaccine.

The CDC said "individuals who have any combination of two doses of an FDA approved/authorized or WHO emergency use listed COVID-19 two-dose series are considered fully vaccinated."

The CDC plans to answer other questions and release a contact tracing order for international air visitors by Oct. 25.

https://www.reuters.com/business/he...-vaccines-international-travelers-2021-10-15/
 
Last edited:
I honestly didn’t even realize that we still have travel restrictions. Living in Texas and seeing what’s happening at the border, I just assumed we dropped them.

My friend's wife is Canadian (I know, what a dumbass) and they had their first kid last year. Her mother got AstraZeneca and has been effectively restricted from being able to see the baby because of it. Biggest tragedy of it all is she's trying to force him to move to Canada because of the whole ordeal.
 
My friend's wife is Canadian (I know, what a dumbass) and they had their first kid last year. Her mother got AstraZeneca and has been effectively restricted from being able to see the baby because of it. Biggest tragedy of it all is she's trying to force him to move to Canada because of the whole ordeal.
Hope he holds out
 
I'm waiting until Hong Kong drops their ridiculous mandatory 21 day quarantine for the fully vaccinated.
 
U.S. confirms it will accept Canadian travellers with mixed vaccines
Announcement follows weeks of speculation as new rules kick in Nov. 8
By Sophia Harris - CBC News | October 15, 2021

canada-us-border-crossing-bc.JPG

The Peace Arch Border Crossing, which connects Surrey, B.C., with Blaine, Wash. The U.S. said on Friday it will begin accepting mixed vaccines from foreign travellers when new rules take effect Nov. 8. (Ben Nelms/CBC)
Canadians with mixed vaccines and U.S. travel plans can breathe a sigh of relief.

Following weeks of speculation, the United States confirmed late Friday it will accept mixed vaccines when new rules kick in on Nov. 8 requiring that foreign travellers entering the U.S. be fully vaccinated.

Individuals inoculated with any combination of two doses of a COVID-19 vaccine authorized by U.S. regulators or the World Health Organization will be considered fully vaccinated, the U.S. Centers for Disease Control and Prevention (CDC) told CBC News.

WHO-approved vaccines include Moderna, Pfizer, AstraZeneca and its Indian-made counterpart, Covishield. So travellers with any combination of these vaccines will be allowed to enter the U.S.

The CDC does not recognize mixing COVID-19 vaccines but said it updated its guidance to reflect growing global acceptance of the practice.

"While CDC has not recommended mixing types of vaccine in a primary series, we recognize that this is increasingly common in other countries so should be accepted for the interpretation of vaccine records," CDC spokesperson Kristen Nordlund said in an email.

Millions of Canadians have mixed doses of COVID-19 vaccines. When the U.S. recently announced it would impose a vaccination requirement for travellers entering by both land and air, many Canadians with mixed doses worried they might soon be barred from entering the country.

"We felt kind of blindsided," said snowbird, Ingrid Whyte of Toronto. Following Canadian government guidance, she and her husband, John, each got one dose of Covishield and a second dose of Pfizer.

'We did all the things we were supposed to do in terms of vaccinations," Whyte said.

The couple had booked a flight to Florida for Nov. 17, but cancelled it due to concerns over their mixed vaccines. They're now relieved to hear their vaccine combination won't be an issue when entering the U.S.

"We are thrilled," Whyte said. "I wish it could have been a little sooner. It would have allowed people to plan a little bit more effectively. But in the long run, it's great news."

It's also good news for Petar Sesar of London, Ont., who has a mix of Moderna and Pfizer.

Sesar's fiancée, Mara Bakula, lives in Cleveland. Sesar welcomed news this week that the U.S. land border will reopen on Nov. 8 to non-essential travellers, as he prefers to drive instead of fly to Cleveland.

However, he worried he might soon have no way of getting to the U.S. if the country rejected his vaccine mix.

"That was a very scary moment," he said. "It felt like house arrest of sorts, like now I [may] have no option."

Earlier this year, the CDC stated online that a mix of two mNRA vaccines, Moderna and Pfizer, would be accepted in "exceptional situations." But Sesar didn't rest easy until he learned that the CDC had approved his exact combination.

"It is unbelievable," he said. "It is such a relief. I share the relief with millions of [Canadians]."

What are the other rules for entering the U.S.?
When the new U.S. travel rules kick in on Nov. 8, travellers will still be on the hook for one or more COVID-19 tests.

Along with showing proof of vaccination, air passengers will still have to show proof of a negative antigen or molecular test taken within three days of boarding their flight to the U.S.

Canadians entering by land won't have to take a COVID-19 test. However, when returning to Canada, all non-essential land and air travellers must show proof of a negative molecular test.

That return test has caused consternation for Canadian daytrippers to the U.S. No matter how short their trip, they will be on the hook for a molecular test, such as a PCR test, that often ranges from $150 to $300 US and can take 24 hours before results are available.

To eliminate the wait for test results, the federal government says Canadians can take their test in Canada, travel to the U.S. and then use that test to return, as long as it's less than 72 hours old.

But that solution doesn't eliminate the high cost of the test.

At a news conference on Friday, Ottawa said that according to the latest data, less than one per cent of fully vaccinated travellers tested positive after being randomly selected to take a COVID-19 test upon arrival. Even so, Chief Public Health Officer Dr. Theresa Tam said Canada's pre-arrival test requirement will remain for now for both unvaccinated and vaccinated travellers.

"We're still at the top of that fourth wave. We're in a situation in Canada where our health systems are still very fragile," she said. "We need to take a precautionary approach in the next little while, and we'll continue to evaluate the situation."

The U.S. has yet to say how it will deal with child travellers too young to get vaccinated. The CDC told CBC News it's working to establish an age requirement for its vaccine mandate.
https://www.cbc.ca/amp/1.6213176
 
FDA clears Moderna and J&J boosters for high-risk groups, allows 'mix and match' shots
By Berkeley Lovelace Jr. | OCT 20 2021


The Food and Drug Administration on Wednesday night authorized booster shots of both Johnson & Johnson's and Moderna's Covid vaccines, another critical step in distributing extra doses to tens of millions of people.

At the same time, U.S. regulators authorized "mixing and matching" vaccines, allowing Americans to get a booster shot from a different drugmaker than the one that made their initial doses.

"Today's actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic," acting FDA Commissioner Dr. Janet Woodcock said in a statement.

"As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death," she added.

The FDA clearance, which was expected, came after the agency's Vaccines and Related Biological Products Advisory Committee last week unanimously recommended additional shots of both vaccines. The committee recommended the Moderna booster for elderly people and at-risk adults six months after they complete their primary series of shots, bringing it in line with the distribution plan for Pfizer and BioNTech's booster. It also endorsed J&J boosters for everyone 18 and older who received the initial shot at least two months ago.

The ruling will now be handed off to the Centers for Disease Control and Prevention and its vaccine advisory committee, which has scheduled a meeting Thursday to discuss Moderna's and J&J's booster data. If the committee issues a recommendation, and CDC Director Dr. Rochelle Walensky signs off, additional shots for those vaccines could be distributed immediately to eligible people.

The authorization would open up booster doses to the more than 15 million people who have been inoculated with J&J's shots and the more than 69 million people who have been fully immunized with Moderna's vaccine.

Eligible Americans will also be able to "mix and match" vaccines. A highly anticipated National Institutes of Health study published last week showed all the combinations of boosters increased antibody levels, though Pfizer's and Moderna's boosters appeared to work best.

The FDA said Wednesday it has identified an increased risk of rare inflammatory heart conditions, myocarditis and pericarditis, following vaccination with the Moderna vaccine, particularly following the second dose. Usually, onset of symptoms has been a few days following vaccination, it said. The observed risk is higher among males under 40 years of age, particularly males 18 through 24.

Pfizer's boosters were authorized less than a month ago to a wide array of Americans, including the elderly, adults with underlying medical conditions, and those who work or live in high-risk settings, such as health-care and grocery workers.

Booster shots have been a contentious topic for scientists — in and outside the government — especially as many people in the U.S. and other parts of the world have yet to receive even one dose of a vaccine. The World Health Organization has pleaded with wealthy countries to hold off on distributing boosters, and some scientists say they aren't convinced most Americans need them right now.

Some committee members said Thursday the boosters should prevent so-called breakthrough infections, which they said is critical for protecting health-care institutions from becoming overwhelmed, while other members said the third shots should ensure those at high risk won't suffer from severe disease. Some on the committee also suggested young people may not need boosters, as the initial shots are still holding up in those groups.

The Biden administration hopes giving the U.S. population additional doses will ensure long-term and durable protection against severe disease, hospitalization and death as the fast-moving delta variant continues to spread.

Unlike Pfizer's and Moderna's two-shot messenger RNA vaccines, J&J hoped to offer a one-shot solution that would protect the public enough to help bring an end to the coronavirus pandemic. But its protection at 72% in the U.S. was viewed by some as inferior to Moderna's and Pfizer's vaccines, which both touted efficacy rates above 90%.

A second dose of J&J's shot boasts similar performance to the mRNA vaccines, boosting protection from symptomatic infection to 94% when administered two months after the first dose in the United States, according to data submitted to the FDA by the company. J&J's vaccine uses a modified adenovirus to induce an immune response.

Still, FDA scientists published an analysis last week on J&J's application for a booster, questioning the strength of the data. The FDA said that people may benefit from a second dose but that the information provided by the company was limited and the agency hadn't verified all of it yet.

Before the vote Friday, many committee members said J&J should be considered a two-dose vaccine much like Moderna's and Pfizer's.

Some committee members even asked the agency whether they could postpone a decision on boosters for J&J recipients, saying it may be too early as there are still a number of outstanding questions. Other members wondered why the agency brought J&J's application before the committee before it was able to verify all of the data.

"Is there an option of saying it's a little early? There are a number of issues that are still outstanding," said Dr. Cody Meissner of Tufts University. "There are a lot of uncertainties, at this point, making it hard to vote for or against this tonight."
https://www.cnbc.com/2021/10/20/fda...rna-booster-shots-for-millions-of-people.html
 
Last edited:
A vaccine (use that term loosely) allows foreigners to now travel...same said vaccine showing very poor results in the actual spread of covid. Like many on here, 80% of the people I know getting covid right now have been given this miracle drug

Good luck. Open it up...regardless of vax. Time to move on from this shit show
 
Opening up travel bans right as a new variant is being passed around, and now a vaccinated person from another country where said variant resides can bring it on over to the US. Two thumbs up fellas.
 
Opening up travel bans right as a new variant is being passed around, and now a vaccinated person from another country where said variant resides can bring it on over to the US. Two thumbs up fellas.


Haha, your fucking President has been welcoming hundreds of thousands of immigrants in through the land border from said variant-afflicted region of the world for fucking months you mug!

Quit crying, those borders are opening up, boi!
 
Vaccinated Canadians who got two different doses in those early vaccine-shortage days can come as well. :)

U.S. will accept mixed doses of vaccines from international travelers

By David Shepardson | October 15, 2021



WASHINGTON, Oct 15 (Reuters) - The U.S. Centers for Disease Control and Prevention (CDC) said late on Friday that it will accept mixed-dose coronavirus vaccines from international travelers, a boost to travelers from Canada and other places.

The CDC said last week that it would accept any vaccine authorized for use by U.S. regulators or the World Health Organization. "While CDC has not recommended mixing types of vaccine in a primary series, we recognize that this is increasingly common in other countries so should be accepted for the interpretation of vaccine records," a CDC spokeswoman said.

The White House said Friday the new vaccine requirements for foreign nationals traveling to the United States will begin Nov. 8 for visitors crossing at land borders as well as international air travelers.

Representative Brian Higgins, a New York Democrat representing a district along the Canadian border, had on Friday asked the CDC if it would accept the mixed vaccine doses noting "nearly four million Canadians, equivalent to 10% of their fully vaccinated population, have received mixed doses of the available mRNA COVID-19 vaccines – this includes the AstraZeneca vaccine."

The CDC said the vaccines approved by the Food and Drug Administration (FDA) for use, as well as those authorized by the WHO, will be accepted for entry into the United States, including the AstraZeneca (AZN.L) vaccine.

The CDC said "individuals who have any combination of two doses of an FDA approved/authorized or WHO emergency use listed COVID-19 two-dose series are considered fully vaccinated."

The CDC plans to answer other questions and release a contact tracing order for international air visitors by Oct. 25.

https://www.reuters.com/business/he...-vaccines-international-travelers-2021-10-15/


glorious. I had just finished the post before and was about to ask about this specifically. I have friends with life on pause, including marriages, because they were mixed vaxed and still didn’t know when they could go over.


Also, very impressive of Japan.
 
Also, very impressive of Japan.

It's pretty incredible consider that Japan was stuck under 6% for what seems to be forever, when all their doctors were exhausted taking care of COVID patients in the ER and the old regulation says only they can give injections.

I guess the plan implemented back in June to allow other medical professionals (like medic, EMTs, dental assistants, etc) to administer the shots and handling some vaccine distributions over to the big companies to take care of their employees has worked.

All in all, it took only about 3 months for Japan to go from under 10% fully-vaccinated to over 70%.
 
Covid vaccine boosters are now available. Here's who's eligible for Pfizer, Moderna and J&J's shots
By Robert Towey | SAT, OCT 23 202



Nearly 100 million people nationwide are immediately eligible to receive Covid booster shots after the Centers for Disease Control and Prevention authorized extra doses of Moderna and Johnson & Johnson's vaccines Thursday night.

The agency's decision also enables fully immunized people to pair their boosters with doses from different manufacturers after research from the National Institutes of Health showed it was safe and effective to mix and match vaccines. Pfizer and BioNTech's boosters were widely cleared for use in the U.S. on Sept. 24.

Some 11.6 million individuals across the country have already received their boosters, and the CDC's approvals opened them up to tens of millions of more people. But not everyone is eligible. Here is who's allowed to get the extra doses in the U.S. based on their first round of shots:

Pfizer-BioNTech
More than 47 million Pfizer vaccine recipients who received both shots at least six months ago became eligible for a booster Friday, according to data presented Thursday before the CDC's advisory committee. That includes:
  • Anyone 65 and older.
  • All adults age 18 to 64 who have cancer, dementia, diabetes, heart disease, HIV and other medical conditions that increase their likelihood of Covid complications.
  • Anyone 18 or older who live or work in a long-term care facility, homeless shelter and prison or other congregate setting.
  • Front-line personnel 18 or older who are at a higher risk of Covid exposure due to their job, including first responders, teachers, supermarket staff and mass transit employees.
Moderna
More than 39.1 million Moderna vaccine recipients who received both shots at least six months ago became eligible for a booster Friday, according to the CDC presentation. The CDC adopted the same criteria for Moderna recipients as Pfizer since the two companies use the same mRNA technology in their Covid vaccines. They include.
  • Anyone 65 and older.
  • All adults age 18 to 64 who have cancer, dementia, diabetes, heart disease, HIV and other medical conditions that increase their likelihood of Covid complications.
  • Anyone 18 or older who live or work in a long-term care facility, homeless shelter and prison or other congregate setting.
  • Front-line personnel 18 or older who are at a higher risk of Covid exposure due to their job, including first responders, teachers, supermarket staff and mass transit employees.
Johnson & Johnson
The CDC adopted a slightly different criteria for J&J's one-shot Covid vaccine, making almost 13 million recipients eligible as of Friday. That includes
  • All adults who were vaccinated with J&J's Covid vaccine at least two months ago, instead of six months with Pfizer and Moderna.
  • All adult J&J recipients are eligible for a booster even if they don't have underlying medical conditions or work in a profession or live where there's a higher risk of Covid.
https://www.cnbc.com/amp/2021/10/23...igible-for-pfizer-moderna-and-jjs-shots-.html
 
U.S Marine Corps Makes It Clear: Get Vaccinated or Get Out
25 Oct 2021 | Military.com | By Konstantin Toropin

covid_0.jpg

The Marine Corps didn't mince words Monday about what will happen to Marines who refuse to get the COVID-19 vaccine by its Nov. 28 deadline: You will be kicked out.

A new message to the force said, "Marines refusing the COVID-19 vaccination, absent an approved administrative or medical exemption, religious accommodation or pending appeal, shall be processed for administrative separation."

Plus, Marines who are considered to have refused the shot already will have their promotions put on hold and will not deploy, and officers will be relieved of command.

The Corps does not consider a Marine to have "refused the vaccine" until any administrative, medical or religious exemptions are considered and decided - though the branch says that, as of Oct. 20, no religious exemptions have been approved for the COVID-19 vaccine.

The deadline should come as little surprise to Marines as the branch's leaders, as well as those of the Navy, have been laying out guidance and deadlines for vaccination for months. In September, leaders in both sea services announced that sailors and Marines would have 90 days to get vaccinated.

A message that followed on Oct. 6 noted that Marines had until Oct. 17 to get the first of the Moderna or Pfizer shots in order to make the deadline, since the branch will consider a Marine fully vaccinated 14 days after their final shot. At this point, Marines who are looking to stay in the service need to get the Johnson & Johnson single-shot vaccine before Nov. 14.

The Marine Corps said that 83% of its active force was fully vaccinated as of Oct. 20; the figure rises to 92% when factoring in partial vaccinations. By contrast, the Navy announced that 93% of active-duty sailors are fully immunized, and 98% have received at least one dose of a vaccine.

The message notes that Marines who are separated for refusing the shot "will not be eligible for involuntary separation pay and will be subject to recoupment of any unearned special or incentive pays and advance educational assistance."

The new message also states that Marine leaders will "retain authority to take any additional adverse administrative or disciplinary action they deem appropriate" in addition to administrative separation.

The Corps' policy follows that of the Navy, which released its own message two weeks ago.

www.military.com/daily-news/2021/10/25/marine-corps-makes-it-clear-get-vaccine-or-get-out.html/amp
 
Scientists link Covid vaccines to rare neurological complications
Study finds Pfizer and Oxford/AstraZeneca jabs have infrequent association with seven illnesses
The BioNTech/Pfizer and Oxford/AstraZeneca coronavirus vaccines are associated with seven rare neurological complications, according to the most comprehensive study of the side effects from the two jabs. Using data from 32m vaccinated adults in England, researchers estimated that an extra 38 people per 10m who received their first Oxford/AstraZeneca shot suffered from Guillain-Barré syndrome, which causes pain and weakness in the limbs and is usually temporary, than would do in the general population.

They found an increased risk of haemorrhagic stroke, a brain bleed, in the 28 days after vaccination with the BioNTech/Pfizer shot, at an estimated 60 extra cases per 10m people. The increased risk was significantly higher in female patients.

A smaller data set from Scotland backed up the association between the AstraZeneca vaccine and Guillain-Barré syndrome, but did not find the same link between the Pfizer shot and haemorrhagic stroke.

Aziz Sheikh, professor of primary care research and development at the University of Edinburgh, emphasised that the adverse events were so rare that they had to report their incidence in millions, rather than thousands. The incidents were measured in the 28 days after vaccination, or a positive test result. “We’re not seeing a higher risk for any of these adverse events associated with the vaccine, than those associated with the infection,” he said.

In fact, people infected with Sars CoV-2, the virus that causes Covid-19, had a substantially higher risk of the seven neurological conditions. The infection causes 145 excess cases of Guillain-Barré syndrome per 10m people, and 123 extra events of encephalitis meningitis and myelitis, inflammations of the brain and spinal cord. There was a higher risk of haemorrhagic stroke in people infected with the virus, but only for the first seven days after testing positive.
Together that's an extra 98 cases per 10m for severe (but non-lethal) side effects, which isn't higher than the increased risk from infection itself, and for comparison's sake, using data published in the last three months on the rate of death for the unvaccinated versus the vaccinated, where the former are 11.4x more likely to die, assuming 100% infection of the same population, in order to simplify, the total number of lives saved by the vaccine per 10m infected is 153,770.

Of course, that figure is a rough & inaccurate extrapolation, since many of the deaths versus all confirmed cases so far occurred before the vaccine was available, but of course, one has to accept that the vaccine is preventing an enormous number of deaths to raise that objection that this estimate more carefully calculated would be downrevised.

That's before you consider the same side effects elevated by the vaccine apparently are more common among those who contract the disease itself. So much for the callous Darwinist opinion that we all just need to contract it naturally to develop antibodies. Not only are you killing people, but you're also more likely to inflict them with severe symptoms following that strategy.
 
10 micrograms is one-third the Pfizer dosage for teenagers and adults.
FDA advisory panel voted to recommend Pfizer's 10-micrograms pediatric vaccine dosage
By Laura Ramirez-Feldman | October 26, 2021



A key federal advisory committee voted Tuesday to recommend emergency authorization of the Pfizer mRNA COVID-19 vaccines for children between the ages of 5 and 11, a sign that the shot will likely be authorized for this age group in the next week.

Following today’s vote, acting FDA Commissioner Janet Woodcock is expected to shortly deliver the agency’s final determination on whether to authorize the vaccine for this age group. Once the FDA gives final approval, the next step is for a CDC vaccine expert panel, the Advisory Committee on Immunization Practices, to review the vaccine’s safety and efficacy. That group would then vote on whether CDC Director Rochelle Walensky should recommend its use. The CDC committee is scheduled to meet on Nov. 2, and the CDC director will likely announce a final decision within hours, meaning these vaccines could be available as early as Nov. 3.

If approved, the Pfizer vaccine will be the first pediatric COVID-19 vaccine. At a White House briefing last week, the Biden administration said it had a plan to ensure these shots were ready to be administered quickly to up to 28 million American children.

“I do think we need it as a tool in our armamentarium for our children, for equity issues, for parents who really would like to protect their children and because of the long-term, very profound implications of schools being disrupted and the social and educational impact that [COVID-19] is having on our children,” said Mark Sawyer, an infectious disease specialist who was one of 17 members who voted in favor of the vaccine for children 5 to 11. One member of the 18-member committee abstained from Tuesday’s vote, while the 17 others voted to approve.

Although children are less likely to get severely ill from COVID-19, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said 1.9 million children between the ages of 5 and 11 have been infected, resulting in 8,300 hospitalizations and more than 2,500 cases of multisystem inflammatory disorder.

“There have also been close to 100 deaths, making it one of the top 10 causes of death in this age range during this time,” Marks said.

According to data presented by Pfizer that was analyzed by the FDA, the mRNA vaccine is more than 90 percent effective against symptomatic disease for children in this age group, and side effects reported in the studies were comparable to those seen in older Americans for which the vaccine has already been approved, the FDA experts said.

After reviewing the safety and efficacy data, the panel of experts recommended that the Pfizer vaccine be given as a series of two doses consisting of 10 micrograms, and administered three weeks apart for children in this age group.

Among some of the concerns brought up by the experts related to vaccinating younger children was the risk of myocarditis, a rare condition that is an inflammation of the heart muscle.

Dr. Matthew Oster, a member of the CDC’s COVID-19 Vaccine Task Force, presented some data on myocarditis to the FDA committee and said so far officials had received 1,640 reports of myocarditis in vaccinated people under 30. The cases include 877 that met the CDC’s case definition for the heart condition, and 637 cases that remained under review.

Myocarditis has been associated with the mRNA vaccines. However, since it has been most commonly reported among young men after the second dose, particularly in ages 18-24, Oster and other experts speculated this might indicate that risk will be smaller for 5- to 11-year-olds than it is for teens.

Another aspect that made the decision difficult for many of the committee members today was the limited data available. The Pfizer trial, which drove the decision, had just 2,268 participants.

"It’s always nerve-racking, I think, when you’re asked to make a decision for millions of children based on studies of only a few thousand children," said Dr. Paul Offit, a vaccine researcher at Children’s Hospital of Philadelphia and a committee member. "The question is, when do you know enough? And I think we certainly know that there are many children between 5 and 11 years of age who are susceptible to this disease who could very well be sick and are hospitalized or die from it,” he added.

Sawyer said deploying the vaccine for these children, however, was the only way to compile this crucial information.

“We are not going to get the data unless we start to use this vaccine,” Sawyer said.

A few things remain unclear based on the data that was presented at the FDA meeting Tuesday. One, it is not clear yet what effects the vaccine will have on transmission for this age group. The Pfizer study wasn’t designed to study this in particular, but Dr. William Gruber, a scientist at Pfizer, said that “real world evidence” has suggested that vaccination reduces transmission in adults, adding that “it’s reasonable to expect that there’ll be some reduction in transmission” for kids.

Another question that remains is whether boosters will later be necessary for these children. According to Pfizer, the company does not have that information at the moment, but expects to know after a six-month follow-up whether antibody levels would decrease in children similarly as they have in vaccinated adults.

Some of the experts also expressed concern about whether the authorization would quickly lead to school vaccination mandates for children 5 to 11. Dr. Cody Meissner, a pediatrician from Tufts University, said school mandates were a major concern given the limited data available.

"I think that would be an error at this time until we get more information about the safety,” Meissner said.

Sawyer added it is important to keep in mind that today’s decision was “going to be a fluid situation,” saying that “an EUA [emergency use authorization] is not a permanent situation and that things could change based on either additional side effects data or depending on what happens with the pandemic.”
https://news.yahoo.com/fda-advisory...zers-vaccine-for-children-5-11-232110554.html
 
Last edited:
Back
Top