FDA could give the green light for Pfizers Covid-19 vaccine Thursday ActionNewsJax.com
Read this article:
FDA could give the green light for Pfizers Covid-19 vaccine Thursday - ActionNewsJax.com
The UK began vaccinating elderly people and medical workers with a vaccine developed by American drugmaker Pfizer and Germany's BioNTech, the world's first rollout.
LONDON, UK Britain's medical regulator warned Wednesday that people with a history of serious allergic reactions shouldnt receive the COVID-19 vaccine from Pfizer and BioNTech as investigators look into whether two reactions on the first day of the countrys vaccination program were linked to the shot.
Professor Stephen Powis, medical director for National Health Service in England, said the advice was issued on a precautionary basis and that the people who had reactions had recovered.
Pfizer and BioNTech said they were working with investigators to better understand each case and its causes.
In the meantime, the Medical and Healthcare Products Regulatory Agency has said people should not received the vaccine if they have had a significant allergic reaction to a vaccine, medicine or food, such as those who have been told to carry an adrenaline shot sometimes called EpiPens or others who have had potentially fatal allergic reactions. The medical regulator also said vaccinations should be carried out only in facilities that have resuscitation equipment.
Such advice isn't uncommon; several vaccines already on the market carry warnings about allergic reactions, and doctors know to watch for them when people whove had reactions to drugs or vaccines in the past are given new products.
The two people who reported reactions were NHS staff members who had a history of significant allergies and carried adrenaline shots. Both had serious reactions, but recovered after treatment, the NHS said.
Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the regulator had done the right thing, but the general public shouldn't be worried about getting the vaccine.
For the general population, this does not mean that they would need to be anxious about receiving the vaccination," he said. One has to remember that even things like marmite can cause unexpected severe allergic reactions.
The warning comes just a day after Britain rolled out its mass vaccination programamid efforts to control a pandemic that has killed more than 62,000 people across the country. The MHRA gave an emergency authorization to the Pfizer-BioNtech vaccine last week, making Britain the first country to approve its widespread use. Canada's regulator authorized the vaccineWednesday.
Even in non-emergency situations, health authorities must closely monitor new vaccines and medications because studies in tens of thousands of people cant detect a rare risk that would affect 1 in 1 million. Authorities have not said how many people have received the shot in Britain so far, but they plan to give 800,000 doses in the first phase, which will target people over 80, nursing home staff and some NHS workers.
Late-stage trials of the vaccine found no serious safety concerns, Pfizer and BioNTech said. More than 42,000 people have received two doses of the shot during those trials.
Detailed data from the vaccine's trials showed potential allergic reactions in 0.63% of those who received the vaccine, compared with 0.51% of those who received the placebo. Reviewers from the U.S. Food and Drug Administration called this a slight numerical imbalance.
Documents published by the two companies showed that people with a history of severe allergic reactions were excluded from the trials, and doctors were advised to look out for such reactions in trial participants who werent previously known to have severe allergies.
As part of its emergency authorization for the vaccine, the MHRA required healthcare workers to report any adverse reactions to help regulators gather more information about safety and effectiveness.
The agency is monitoring the vaccine rollout closely and will now investigate these cases in more detail to understand if the allergic reactions were linked to the vaccine or were incidental, Powis said. The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well.
Dr. June Raine, head of the medical regulatory agency, informed a Parliamentary committee about the reactions during previously scheduled testimony on the pandemic.
We know from the very extensive clinical trials that this wasnt a feature of the vaccine, she said. But if we need to strengthen our advice, now that we have had this experience in the vulnerable populations, the groups who have been selected as a priority, we get that advice to the field immediately.
Read more from the original source:
UK probing if allergic reactions linked to Pfizer vaccine - KING5.com
WEST SPRINGFIELD, Mass. (WWLP) A poll conducted in November by MassINC Polling Group reported the majority of Massachusetts residents plan to get the vaccine once available.
Side effects of both Moderna and Pfizers vaccine have been shown to be mild to moderate soreness, muscle aches, fever, and fatigue that ended in one to two days.
The data and safety monitoring board, an independent group of experts via the National Institutes of Health, found side effects of the Moderna trial vaccine were more pronounced after the second dose. But health experts dont expect any severe long term side effects.
22News spoke to a woman who hopes to be one of the first to get the vaccine.
I think Im going to be second or third in line to get it and I think its worth getting. I dont see any reason why people would be scared to take it. Its just going to give you peace of mind. Arline Ely of West Springfield
United Kingdom health regulators say people who have a significant history of allergic reactions shouldnt get the Pfizer vaccine after two people had adverse reactions but both people are recovering well and the UK is investigating the cause.
U.S. documents from the FDA say Pfizers vaccine was strongly protective against coronavirus and ultimately appeared safe.
More here:
COVID-19 vaccine side effects of both Moderna and Pfizer - WWLP.com
TUCSON (KVOA)- Viewers have been emailing in their questions regarding getting a coronavirus vaccine when it is available in Arizona.
One viewer asked: "It is reported that people who had COVID-19 now have some immunity to the virus. Will they also be first in line with their groups to get the vaccine or will they be encouraged to wait for a later round?"
Holly Poynter from the Arizona Department of Health Services said that a previous COVID-19 positive diagnosis does not prevent a person from receiving a vaccine or hinder the vaccine's ability to work effectively.
In regards to if you have to be a permanent resident of Arizona to receive a COVID-19 vaccination in Arizona. The answer is no.
"Place of permanent residence doesn't factor into whether someone can get vaccinated in Arizona and what a person's priority will be," said Poynter.
As for some viewers wondering how much this vaccine will cost, Gov. Doug Ducey announced during a coronavirus briefing that the COVID-19 vaccine will be free.
The rest is here:
View original post here:
The authorization under consideration for the Pfizer/BioNTech vaccine would be for "individuals 16 years of age and older." John Nacion/SOPA Images/LightRocket/Getty Images hide caption
The authorization under consideration for the Pfizer/BioNTech vaccine would be for "individuals 16 years of age and older."
The Food and Drug Administration released a detailed analysis Tuesday morning of the COVID-19 vaccine from Pfizer and its partner BioNTech ahead of a Thursday meeting of a group of independent experts that will advise the agency on whether to grant the vaccine an emergency use authorization.
The agency's analysis finds "no specific safety concerns identified that would preclude issuance of an EUA." Serious reactions were rare. Side effects are common, however, with a majority of study volunteers experiencing reactions at the site of injection, headaches and fatigue.
The analysis also affirms the previously stated vaccine effectiveness of 95%, assessed a week after two doses of vaccine. The vaccine doses are given 21 days apart.
The clinical data also suggest that the vaccine may be able to prevent COVID-19 after the first dose 82% effective though the FDA analysis says the available information doesn't allow for a firm conclusion on that potential effect.
The vaccine authorization under consideration is "for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older."
On Thursday, the Vaccines and Related Biological Products Advisory Committee, an advisory group, will discuss the vaccine in an open public meeting.
The agency will ask the experts to assess whether the available scientific evidence supports the proposed emergency use of the vaccine. Specifically, the committee will be asked whether the known and potential benefits of the vaccine outweigh its known and potential risks in people 16 and older.
The FDA will also ask the experts to weigh in on what additional studies should be done by the companies to further elucidate the safety and effectiveness of the vaccine after it is available under an EUA.
Continue reading here:
FDA Analysis Supports Emergency Use Of Pfizer COVID-19 Vaccine : Shots - Health News - NPR
New CarsUsed Cars
MakeAcuraAston MartinAudiBentleyBMWBuickCadillacChevroletChryslerDodgeFerrariFiatFordGMCHondaHyundaiInfinitiJaguarJeepKiaLamborghiniLand RoverLexusLincolnLotusMaseratiMaybachMazdaMcLarenMercedes-BenzMINIMitsubishiNissanPorscheRAMRolls-RoyceScionSmartSubaruTeslaToyotaVolkswagenVolvo
Model
Price$1,000$2,000$3,000$4,000$5,000$6,000$7,000$8,000$9,000$10,000$11,000$12,000$13,000$14,000$15,000$16,000$17,000$18,000$19,000$20,000$21,000$22,000$23,000$24,000$25,000$30,000$35,000$40,000$45,000$50,000$75,000$99,000$99,000+
Distance10 Miles20 Miles30 Miles40 Miles50 Miles75 Miles100 Miles150 Miles250 Miles500 Miles
of
Search Cars
Powered by Cars.com
More here:
Every state has its own COVID-19 vaccine distribution plan. Find the one for yours here. - USA TODAY
Vaccine testing continues to expand, but some groups could be left waiting till late 2021
FORT WORTH, Texas As a Cook Childrens pediatrician, Dr. Jason Terk is both at the front of the line to get vaccinated for COVID-19 and fielding constant questions from curious parents about vaccinating their children.
The COVID-19 questions come pretty much every day, he said. I think the most important message for parents to know is that vaccines are not only safe and effective but absolutely necessary.
For many kids, though, it wont be an option just yet.
Children are not little adults, Terk said. We have to understand that their biological systems are not just miniature versions of us.
Pfizers vaccine, likely to ship out first, has been tested in kids 12 years and older.
In a statement, a Pfizer spokesperson said:
We have submitted available safety data for the approximately 100 trial participants in the 12-15-year-old cohort who have received their second dose. The data will be submitted as part of Thursdays Vaccines and Related Biological Products Advisory Committee meeting and we will address any questions on these data then.
Moderna hasnt started testing in children but plans to soon.
I promise you I started getting calls the last two weeks already of the patients whose parents want to have the vaccine for them, said Dr. Flor Munoz, a pediatric infectious disease professor at Baylor College of Medicine.
She believes it could be the end of 2021 before approval of vaccines goes down to the infant level. She says globally the AstraZeneca vaccine has been tested on children down to the age of 5 years old.
We need to make sure that the dose that we give them is going to be safe in terms of not giving them a lot of reactions, which could happen with younger children, she said.
Its unclear where children would fall in the distribution line if the vaccines are authorized for them. Munoz expects those with underlying health conditions like heart and lung diseases or obesity could be grouped together with all at-risk health groups.
While children play a key role in spreading the virus, most arent at high-risk, so Munoz says there was less urgency in testing the vaccine on them.
Pregnant women, though, do struggle more with the virus and are more likely to end up hospitalized than non-pregnant women the same age. They also havent been included in testing. Munoz expects that to happen before infant approval happens.
The reason I said it might be sooner is they're adults, so it's easier to make a bridge or a comparison between non-pregnant healthy adults and pregnant adults, Munoz said.
Regardless of the timeline, Munoz and Terk say when a vaccine is authorized or approved for adults and children, everyone should be confident it will be safe. They worry about anti-vaccine entities attempting to stir up misinformation and myths.
Of course, I would take it and of course people should take it, Munoz said.
I'm looking forward to getting mine, Terk said. Unfortunately, we had a witness to the outbreaks of measles and other vaccine-preventable diseases that are simply self-imposed wounds.
For now, their advice is to get caught up on the flu shot and keep masking and distancing.
It's extremely important that we maintain our vigilance, even after COVID-19 vaccines are deployed, Terk said.
Excerpt from:
What we know about the COVID-19 vaccine in children and pregnant women - WFAA.com
Read this article:
LONDON (Reuters) - William Shakespeare from Warwickshire in England was one of the first people to receive the newly approved COVID-19 vaccine outside a clinical trial on Tuesday.
The 81-year-old had the injection at University Hospital Coventry on Tuesday, 20 miles from Stratford-Upon-Avon, the birthplace of his namesake, Englands greatest dramatist and poet.
Shakespeares shot inspired Twitter users, who joked The Taming of the Flu, The Two Gentlemen of Corona. Some asked if Margaret Keenan was patient 1A, then was Shakespeare Patient 2B or not 2B?.
Reporting by Paul Sandle; editing by Guy Faulconbridge
Link:
In England, William Shakespeare receives a COVID-19 vaccine - Reuters UK
