Pfizer Becomes First Covid Vaccine To Gain Full Fda Approval
Pfizer’s two-dose Covid-19 vaccine has received full approval from the US Food and Drug Administration – the first jab to be licensed in the nation.
The vaccine had initially been given emergency use authorisation. Its two jabs, three weeks apart, are now fully approved for those aged 16 and older.
The approval is expected to set off more vaccine mandates by employers and organisations across the country.
It comes amid lingering vaccine hesitancy among many Americans.
In a statement, the FDA said its review for approval included data from approximately 44,000 people. The vaccine, which will now be marketed as Comirnaty, was found to be 91% effective in preventing Covid disease.
Acting FDA commissioner Janet Woodcock said that the public “can be very confident” the vaccine meets high safety, effectiveness and manufacturing quality standards.
It still has emergency use authorisation for children aged 12 to 15.
Following the announcement, the US military said they would officially require all 1.3m active duty US troops to get vaccinated.
The jabs are being provided at no cost to Americans.
The FDA initially gave Pfizer temporary authorisation – a clearance given if the agency determines the benefits of a product outweigh potential risks during a public health emergency.
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It is important to note that the number of people who participated in the initial COVID-19 safety studies was similar to that in the safety studies of other commonly used vaccines, including vaccines for tetanus, diphtheria, whooping cough and meningitis. Over 43,000 adults participated in the early phases of the Pfizer BioNTech clinical trial, over 30,400 in Modernas and over 44,000 in Johnson and Johnsons. Half the participants in each study were given a vaccine, while the other half were given a placebo.
Where EUA and full approval differ
From this point on, emergency use authorization and full FDA approval for COVID-19 vaccines follow different clinical study requirements.
For the emergency use authorization, the FDA requires at least half of the participants of the original studies to be followed for at least two months post-vaccination. This is because the vast majority of vaccine-related side effects occur right after vaccination.
Full FDA approval, on the other hand, requires participants in the original studies to be followed for at least six months. Reviewers look at data from the same study participants but collected over a longer period of time. All adverse events are examined. The manufacturer must also provide more detailed manufacturing plans and processes, as well as a higher level of oversight and inspections. All of this adds significantly more time to the review process.
Different timelines, same rigorous requirements
Fda Advisors Approve Emergency Use Of Pfizer Vaccine In Children 5 To 11
TUESDAY, Oct. 26, 2021 — A U.S. Food and Drug Administration advisory panel voted Tuesday to recommend emergency use of a smaller dose of the Pfizer COVID-19 vaccine for children aged 5 to 11 years, advancing plans to offer the shots to 28 million young children across the United States.
The vote was nearly unanimous at 17 to 0, with one abstention, and the FDA is expected to make a final ruling in a matter of days.
If approved by the FDA and then the U.S. Centers for Disease Control and Prevention, the Pfizer pediatric vaccine would involve a two-dose series of 10-mcg shots, about one-third of the dosage administered to adults and children aged 12 years or older. Two doses of the Pfizer vaccine are nearly 91 percent effective in preventing symptomatic illness in young children and bring no unexpected safety issues, according to a study posted Friday by the FDA.
The CDC vaccination advisors are now set to meet Nov. 2 to weigh in on the pediatric vaccine. Once they have spoken, CDC Director Rochelle Walensky, M.D., is expected to sign off on the panel’s recommendation. After that comes the Biden administration plans to roll out the vaccine through pediatricians’ offices, community clinics, and pharmacies, as they hope to reassure hesitant parents that the vaccine will protect their children from COVID-19.
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Thrombosis With Thrombocytopenia Syndrome After Vaccination With J& j/janssen Covid
After receiving the J& J/Janssen COVID-19 Vaccine, there is risk for a rare but serious adverse eventblood clots with low platelets . Women younger than 50 years old should especially be aware of their increased risk for this rare adverse event. There are other COVID-19 vaccines available for which this risk has not been seen.
This adverse event is rare, occurring at a rate of about 7 per 1 million vaccinated women between 18 and 49 years old. For women 50 years and older and men of all ages, this adverse event is even more rare.
Cases of myocarditis and pericarditis in adolescents and young adults have been reported more often after getting the second dose than after the first dose of one of the two mRNA COVID-19 vaccines, Pfizer-BioNTech or Moderna. These reports are rare and the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks, including the possible risk of myocarditis or pericarditis.
Can I See The Safety And Effectiveness Data That Support The The Approval Of Comirnaty And The Emergency Use Authorization Of The Covid
The FDA is publicly sharing information about COVID-19 vaccines so you can see the evidence for yourself. The FDAs analysis of clinical trial data, including but not limited to demographic information about the clinical study volunteers, is available in the Summary Basis for Regulatory Action for Comirnaty and the decision memos that explain FDAs basis for authorizing each vaccine for emergency use. In addition, for the authorized vaccines, an FDA Briefing Document for the Vaccines and Related Biological Products Advisory Committee is available, as noted below.
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Do Americans Think This Will Change Minds
- Folks who don’t want the vaccine are going to convince themselves not to get it one way or another, which is why the Biden administration has to be as consistent as possible with their mandates and information. – Greg Samuel, 33, Washington DC
- Maybe 50% of people who haven’t been vaccinated have said they’d prefer an FDA approval. So with the approval, what’s the excuse? I’m hopeful the seal of approval will give them confidence. I’m optimistic, but I don’t think it’s going to change too much. – Dr Mireya Wessolossky, 58, Massachusetts
- I would still like to see how it affects people in the next few years before getting vaccinated. This vaccine has only been out for less than a year. – Jenson Bland, 21, Georgia
Wait What Fda Wants 55 Years To Process Foia Request Over Vaccine Data
The Food and Drug Administration headquarters in White Oak, Maryland, August 29, 2020. REUTERS/Andrew Kelly
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– Freedom of Information Act requests are rarely speedy, but when a group of scientists asked the federal government to share the data it relied upon in licensing Pfizers COVID-19 vaccine, the response went beyond typical bureaucratic foot-dragging.
As in 55 years beyond.
Thats how long the Food & Drug Administration in court papers this week proposes it should be given to review and release the trove of vaccine-related documents responsive to the request. If a federal judge in Texas agrees, plaintiffs Public Health and Medical Professionals for Transparency can expect to see the full record in 2076.
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The 1967 FOIA law requires federal agencies to respond to information requests within 20 business days. However, the time it takes to actually get the documents will vary depending on the complexity of the request and any backlog of requests already pending at the agency, according to the governments central FOIA website.
Justice Department lawyers representing the FDA note in court papers that the plaintiffs are seeking a huge amount of vaccine-related material about 329,000 pages.
Civil division trial lawyer Courtney Enlow referred my request for further comment to the DOJ public affairs office, which did not respond.
Siri declined comment.
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Hawaii Governor Urges Tourists To Stay Away As Coronavirus Surges
Gov. David Ige of Hawaii asked visitors not to travel to the islands unless it is for essential business purposes, as high numbers of coronavirus cases strain the states hospitals.
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We are seeing more Covid patients in our hospitals and the I.C.U.s are filling up. We need to take action now in order to reduce the spread of Covid and ensure that our hospitals are not overrun. I did ask everyone, residents and visitors alike, to reduce travel to Hawaii to essential business activities only. We do know that it is not a good time to travel to the islands. Restaurant capacity has been restricted. There is limited access to rental cars and we know that the visitors who choose to come to the islands will not have the typical kind of holiday that they expect to get when they visit Hawaii. Our call to reduce travel to the islands to only essential businesses will have an impact on the numbers who have come here. But I also would like to point out that our hospitals are at capacity, our I.C.U.s are full. We are working on surge plans at every facility to expand capacity. Were transitioning acute care beds to be able to support those who are sick. And so I do know that thats a risk. But I believe that as a community, thats a risk we have to take to discourage travel to the islands until we can get to a better place with our health care facilities.
Facing a surge of Covid-19 cases that is straining hospitals, Gov. David Ige of Hawaii asked tourists to stay away.
Fda Authorizes Pfizer Covid
The Food and Drug Administration granted emergency use authorization to the Covid-19 vaccine developed by Pfizer and its partner BioNTech Friday for children ages 5 to 11, a significant step toward making the vaccine available to millions of school-age children.
Before the vaccine becomes widely available, it will also need to be recommended by the Centers for Disease Control and Prevention. The decision on that recommendation is made after a meeting of an expert committee, the Advisory Committee on Immunization Practices, or ACIP. The CDC director must then approve ACIPs recommendations. That committee is scheduled to meet on Nov. 2.
As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for todays authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy, said acting FDA Commissioner Janet Woodcock, in a statement. Our comprehensive and rigorous evaluation of the data pertaining to the vaccines safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.
The Pfizer-BioNTech Covid vaccine for children 5 to 11 should be given as two doses three weeks apart, just like the version for older children and adults, but uses a lower 10-microgram dose, one-third the adult dose.
Still, those concerns could still prove a topic of debate for the ACIP when it meets next week.
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Fda Approves First Drug For Genetic Cause Of Dwarfism
The Food and Drug Administration approved the first treatment for the most common cause of dwarfism Friday, a drug that has proved to increase childrens height but has been polarizing among adults with short stature.
The treatment, developed by BioMarin Pharmaceutical, is a once-daily injection for children with achondroplasia, a rare genetic disorder that results in dwarfism and can lead to serious medical complications. In a pivotal clinical trial, patients who got the drug, called Voxzogo, grew 1.6 centimeters more over the course of a year than those who received placebo. That means patients who take Voxzogo throughout childhood are likely to reach heights similar to their peers who dont have achondroplasia, according to BioMarin.
Its the difference between being able to drive a car or not, reaching stuff in closets, being able to take care of your hygiene, said Jean-Jacques Bienaimé, BioMarins CEO. It would make a huge difference for those patients. Theres no question about it.
BioMarin does not yet have data on whether Voxzogo can prevent the hearing loss, sleep apnea, and life-threatening skeletal problems that can result from achondroplasia, complications that take years to develop. To some, the companys focus on height and the FDAs willingness to approve drugs based on their ability to make patients taller threatens to undermine years of advocacy without offering a guaranteed benefit.
A Passengers Death Highlights Challenges Cruise Lines Face As Cases Surge
As the highly contagious Delta variant of the coronavirus surges around the world, the health and safety protocols established by a cruise industry struggling to fight its way back from the pandemic are being put to the test.
In a grim example of the challenges facing cruise lines, 27 coronavirus infections were identified over two weeks in late July and early August aboard the Carnival Vista ship that had sailing out of Galveston, Texas.
One of the infected, Marilyn Tackett, a 77-year-old passenger from Oklahoma, later died.
Ms. Tacketts death came about a week before the Centers for Disease Control and Prevention issued a new advisory, warning people with increased risk for severe illness from Covid-19 to avoid travel on cruise ships, regardless of their vaccination status.
Carnival is not the only cruise line to have seen an uptick in cases. Earlier this month, Royal Caribbean had six guests test positive onboard its Adventure of the Seas ship.
The companies have responded to the recent increase in cases by introducing pre-departure testing requirements for all passengers. Carnival also added a mask mandate on Aug. 7 for all vaccinated and unvaccinated guests in indoor areas and banned smoking in the casino.
The cruise line had not tested vaccinated passengers before embarking.
But Mr. Bayley said: Testing captures status at a point of time and if the guest is incubating infection, then the test will miss it.
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Covid Concerns In Kabul Are An Afterthought Amid Evacuation
At Hamid Karzai International Airport, where thousands of U.S. troops and NATO allies are trying to evacuate citizens and Afghans desperate to flee their country after the Taliban took control of Kabul last week, the coronavirus is an afterthought.
The speed, size and scope of the evacuation operation which came together rapidly as U.S. officials were caught off guard by the Talibans swift offensive have meant that few measures, if any, are in place to help prevent the spread of the disease and its newer, more aggressive variants.
There is no testing of the thousands of passengers passing through the base, in what has turned into the final operation of the United States nearly 20-year-old war in Afghanistan. Social distancing is nonexistent as hundreds of Afghans are ferried in from the airports gates, held in crowded parking lots or tents and processed in packed terminals.
The U.S. military cargo aircraft responsible for carrying a large number of Afghan refugees to bases in the Middle East and Europe are packed with 300 to 400 passengers at a time who sit practically knee-to-back on the floor.
Coronavirus testing usually takes place at American bases outside Afghanistan, where passengers are tested and isolated if found to be positive. Before the government of Afghanistan collapsed, its ministry of public health had reported a third wave of coronavirus infections in the country, with a record number of positive cases and deaths.
What Safety Information Is Available About Covid
The FDA evaluated data from clinical studies that included tens of thousands of people for Comirnaty, the FDA-approved COVID-19 vaccine, and for each of the COVID-19 vaccines authorized for emergency use.
The FDA has authorized three vaccines for emergency use because the data from clinical studies clearly showed that the known and potential benefits of the FDA-authorized COVID-19 vaccines outweighed the known and potential risks.
Approved COVID-19 Vaccine
The data to support the decision to approve Comirnaty builds on extensive data and information that supported the Pfizer-BioNTech COVID-19 Vaccine EUA , including information about the vaccines safety and effectiveness. The safety of Comirnaty was evaluated in individuals 16 years of age and older, approximately 22,000 of whom received the vaccine and 22,000 of whom received placebo. More than half of the clinical trial participants were followed for safety follow-up for at least four months after the second dose. After issuance of the EUA, clinical trial participants were unblinded in a phased manner over a period of months to offer placebo recipients the Pfizer-BioNTech COVID-19 Vaccine. Overall, in blinded and unblinded follow-up, approximately 12,000 vaccine recipients have been followed for at least 6 months.
Allergic Reactions
Myocarditis and Pericarditis Following Vaccination with Comirnaty, Moderna and Pfizer-BioNTech COVID-19 Vaccines
Guillain Barré Syndrome Following Vaccination with Janssen COVID-19 Vaccine
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Fda Approval Could Spur More Vaccine Mandates
The FDA’s decision could still have an indirect effect on future vaccination rates by making it easier for companies, schools, and government agencies to implement vaccine mandates.
Prior to the FDA approval, schools and businesses were wary of the legal implications of requiring COVID-19 vaccines, since the shots were only authorized for emergency use.
Already, the FDA’s recent approval has ushered in a spate of new mandates.
Almost soon as the Pfizer shot was fully approved, the Pentagon announced that it would require all 1.4 million service members in the US military to get vaccinated. On Thursday, President Joe Biden is expected to issue executive orders that require most federal workers and contractors to be vaccinated.
Disney World has announced that its union workers would have to get vaccinated by October 22. And CVS Health said corporate employees and pharmacists would have to get vaccinated by October 31.
Many universities including the University of Minnesota, State University of New York, Ohio State University, and most public Louisiana universities instated similar mandates immediately following the FDA announcement.
Already, vaccine requirements at lots of schools prompt people to get the polio and measles vaccines and there’s reason to believe they’ll work again. Around 43% of unvaccinated people surveyed in the Ipsos poll said they would likely get a COVID-19 shot if their employer required it.