Category: Covid-19 Vaccine

Vaccine rates for this week were 21% higher than the week before and 34% higher compared to two weeks ago, according to DOH data.

OLYMPIA, Wash. More Washington residents are getting vaccinated against COVID-19 as fears over the Delta variant, and unemployment, push more people to seek out the shot.

According to the Washington State Department of Health, the vaccination rate for this week is 21% higher than last week and 34% higher compared to two weeks ago. Health officials say spiking COVID-19 cases and recent vaccination mandates may be driving the increase.

Earlier this month Governor Jay Inslee announcedvaccines will be mandatory for most state employees, and all health care workers in October. A week later he expanded the mandate to include anyone who works on a school campus, from pre-school through state colleges.

Thurston County has seen its vaccination numbers steadily climb through the month of August. Just under 300 people received vaccinations during the first week of the month. The second week more than 350 people sought out the vaccine. A week later, more than 580 people got the shot.

Thurston County is seeing its highest vaccination numbers since the early spring when more people became eligible for the vaccine, according to a county health department spokesperson.

At the county's drop-in clinic at the Capital Mall, a state employee who came to get the shot said he was only getting vaccinated to save his job.

Ryan Harrison, a specialist in the Army, now has to get vaccinated, but he said he decided to for health reasons.

I realized what I read online is not true, Harrison said.

Harrison had been hesitant to get the vaccine because of what he read online about side effects and long-term effects.

"I've had friends who are vaccinated who have made me have a change of heart, to be honest, he said.

The Tacoma-Pierce County Health Department is calling on doctors to boost vaccine rates in the county.

The departments blog includes personal testimony of doctors and physicians assistants, including Jeff Boulet.

Boulet is a physicians assistant in Bonney Lake.

In his video featured on the departments blog, Boulet tells the story of a patient who was reluctant to get the vaccine.

"I had a patient die within the last week. And I had this conversation with him 2 months ago and he chose not to get the vaccine, Boulet said. That's the kind of sad story you hear and they really hit home."

Before the vaccine was available, Boulet got COVID-19.

He had shortness of breath for months and still has daily muscle pains. Boulet used to climb mountains, an activity thats been much more difficult post-COVID.

"I'm not here to tell my patients vaccine is completely without risk, there's a risk in everything we do, Boulet said. I'm here to say, however, that Ill take my chances all day with the vaccine versus getting the actual COVID itself."

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COVID-19 vaccinations increase in Washington following mandates, spike in cases - KING5.com

In the race to get Americans vaccinated, two groups are commanding a lot of attention: Republicans and white evangelicals. Both are less likely to have been vaccinated already and more likely to refuse vaccination altogether.

But its the overlap between white Republicans and white evangelicals that is especially telling, as white evangelical Republicans are among the most likely groups in the U.S. to refuse vaccination. According to a June survey by the Public Religion Research Institute, where Im the research director, and the Interfaith Youth Core, white evangelical Republicans were considerably less likely to say they were vaccinated or planning to get vaccinated as soon as possible (53 percent) than Republicans who were not white evangelicals (62 percent). Moreover, white evangelical Republicans were the most likely of any large subgroup we surveyed to say they were refusing to get vaccinated (26 percent).

That the combination of being a Republican and a white evangelical would form a particularly toxic anti-vax stew, more significant than party or religion alone, seems obvious to me, but then again, I grew up in rural Texas I see this combination of beliefs in motion every day on Facebook, where Im connected to many high school and college classmates.

According to PRRIs 2020 religion census, the county where I lived longest as a kid (Leon) is 72 percent white Christian, including 44 percent white evangelical, and election data shows 87 percent of the county voted for former President Donald Trump in 2020. Just over one-third of the countys eligible population is fully vaccinated, even though COVID-19 case rates are higher than they have ever been. At least three people who went to high school with me have died, while tracking statistics say at least 1 in 9 Leon County residents have been ill almost as many as in New York City (1 in 8), one of the hardest-hit areas in the country, and well over the rate in Washington, D.C. (1 in 13), where I live now.

This is significant because Leon County is extremely rural, with less than 20,000 total residents, including less than 2,000 in Buffalo, the town I lived near. For reference, my high school has only about 260 students at any given time. If you need ICU treatment, you have to travel there are currently no hospitals with ICUs in the county.

But what is also significant about Leon County is the role religion has played in residents low vaccination rates even when faced with death from the coronavirus. When my classmates were hospitalized with COVID-19, there were repeated calls for prayers and proclamations that God would provide healing. When they died, those prayer requests became comments that God called [them] home.

The belief that God controls everything that happens in the world is a core tenet of evangelicalism 84 percent of white evangelicals agreed with this statement in PRRI polling from 2011, while far fewer nonwhite, non-evangelical Christians shared this belief. The same poll also showed that white evangelicals were more likely than any other Christian group to believe that God would punish nations for the sins of some of its citizens and that natural disasters were a sign from God. Whats more, other research from the Journal of Psychology and Theology has found that some evangelical Christians rationalize illnesses like cancer as Gods will.

This is why I remember friends and acquaintances in Leon County when I think about how religious beliefs influence ones attitude toward COVID-19 and vaccination. PRRIs March survey found that 28 percent of white evangelical Republicans agreed that God always rewards those who have faith with good health and will protect them from being infected with COVID-19, compared with 23 percent of Republicans who were not white evangelicals. And that belief correlates more closely with vaccination views among white evangelical Republicans 44 percent of those who said God would protect them from the virus also said they would refuse to get vaccinated. That number drops to 32 percent among Republicans who are not white evangelicals.

Complicating matters further, the pandemic also fits neatly into end times thinking the belief that the end of the world and Gods ultimate judgment is coming soon. In fact, nearly two-thirds of white evangelical Republicans (64 percent) from our March survey agreed that the chaos in the country today meant the end times were near. Faced, then, with the belief that death and the end of the world are a fulfillment of Gods will, it becomes difficult to convince these believers that vaccines are necessary. Sixty-nine percent of white evangelical Republicans who said they refused to get vaccinated agreed that the end times were near.

Moreover, given how many white evangelicals identify as Republican or lean Republican about 4 in 5 per our June survey disentangling evangelicals religious and political beliefs is nearly impossible. Consider how many white evangelical leaders like former Liberty University President Jerry Falwell Jr. downplayed the severity of the pandemic in line with Trump. Falwell was hardly the only evangelical leader to do this either. If anything, the pattern of white evangelical resistance to vaccination has reached the point where some white evangelical leaders who might otherwise urge vaccination hesitate to do so because of the political climate.

In the same survey, about 2 in 5 white evangelical Republicans (43 percent), and Republicans more broadly (41 percent), said one reason they hadnt gotten vaccinated was that the COVID-19 pandemic had been overblown.

It is perhaps unsurprising, then, that most white evangelical Republicans, and Republicans in general, disagreed with our question about the Golden Rule, that because getting vaccinated against COVID-19 helps protect everyone, it is a way to live out the religious principle of loving my neighbors (57 percent and 58 percent, respectively). This may be because for some white evangelicals and Republicans, politics and religion are inseparable and Gods will, or their interpretation of it, controls everything.

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Why Some White Evangelical Republicans Are So Opposed To The COVID-19 Vaccine - FiveThirtyEight

Misinformation about the impact of COVID-19 vaccines on pregnant people and how it may affect fertility and menstruation have spread like wildfire, triggering warnings from health professionals that not enough pregnant women are getting jabbed.

But studies have yet to link any vaccine-related problems with pregnancy and foetal development, or menstrual cycles and fertility in women or men. In fact, studies and experts say it is more dangerous not to get the vaccine.

The latest data from the Centers for Disease Control and Prevention (CDC) in the United States concluded that COVID-19 vaccines are well-tolerated by people who are pregnant, planning a pregnancy or lactating, further suggesting the benefits of having the vaccine far outweighs the risks.

The CDC study is one of the largest of its kind and drew data from a survey of more than 17,000 individuals.

To understand the data behind various studies and to get the facts, Euronews Next spoke to Dr Liudmila Mosina, Technical Specialist on Vaccine-preventable Diseases and Immunization at the World Health Organization (WHO) regional office for Europe.

Dr Mosina: WHO recommends vaccinating pregnant women when the benefits of vaccination outweigh the potential risks.

The information we have got from studies conducted after the introduction of the mRNA vaccines, showed that pregnant women develop antibodies after the vaccination and these antibodies are actually transported in cord blood and breast milk. This suggests that the vaccination will protect not only pregnant women but also their children at an early age.

A recent population-based study from Israel showed that vaccinated pregnant women had a significantly lower risk of COVID-19 infection.

Dr Mosina: We know that pregnant women are at higher risk of severe COVID-19 diseases than women in reproductive age who are not pregnant. We have seen multiple (pieces of) evidence that proves this.

Pregnant women face a higher risk of admission into intensive care units if they get COVID-19 or can be at a higher risk of invasive ventilation.

COVID-19 in pregnancy also poses a risk for babies. Pregnant women who get COVID-19 during the pregnancy have a higher risk of premature delivery and their children are at a higher risk of needing intensive care. These are facts that we know today.

Dr Mosina: When women discuss the vaccine with their medical doctor and it's clear that the benefits of vaccination outweigh the risk, then they should be vaccinated right away to protect them against this disease and all the severe complications that can happen.

Dr Mosina: Public health recommendations are continuously changing as new, strong evidence is brought to light.

When the first COVID-19 vaccines became available, WHO experts recommended vaccinating pregnant women who were at high risk of acquiring the disease, i.e. healthcare workers in contact with COVID-19 patients. Back then, we did not have enough data on the safety and efficacy of the vaccination for pregnant women as they were not part of initial clinical trials.

Now we have more evidence on increased risk of severe COVID-19 outcomes in pregnant women. The real-life data from vaccine safety monitoring did not reveal any additional safety signals.

Data from post-introduction studies on mRNA vaccines suggest that vaccination of pregnant women leads to development of protective antibodies and reduces their risk of COVID-19 infection. These new data allowed WHO to update recommendations on vaccinating this group.

Dr Mosina: Available data suggest that there is no risk to the fetus. Early real-life data on safety of mRNA vaccines in pregnant women came from the US, which has a well-established vaccine safety monitoring system. These data did not reveal any additional safety signals for pregnant women or their children.

Other smaller studies also confirmed development of protective antibodies in vaccinated pregnant women, effectiveness of mRNA vaccines in preventing COVID-19 infection, and potential protection of babies.

All COVID-19 vaccines included in the WHO List for Emergency Use are not live vaccines, so they cannot cause disease in women or in their babies.

Myths that COVID vaccines can cause infertility and even erectile dysfunction have done the rounds on social media.

A survey published in March that was conducted in the United Kingdom revealed about a quarter of young women did not want to get the COVID vaccine as they were worried about their fertility.

And in July, Google searches for infertility linked to COVID-19 vaccines increased by nealy 34,0000 per cent.

Despite the fears and misinformation, the vaccine has no known proof that COVID vaccines can affect fertility, according to the WHO.

Dr Mosina: WHO recommends COVID-19 vaccines to all people, including those who plan to have children. Vaccination should not be a reason to postpone or avoid pregnancy. There is no evidence that any vaccines, including COVID-19 vaccines, affect fertility in women or men, she said.

Since the COVID-19 vaccination was rolled-out, many vaccinated women became pregnant without any problems. WHO continues monitoring safety of COVID-19 vaccines, including their impact on fertility.

On blogs and across social media, women have shared their stories of a change to their menstrual cycle, such as changes to the regularity and volume (heavier or lighter periods).

A study said it is unclear whether apparent changes are due to COVID-19 infection/illness itself, or other pandemic-related factors like increased psychological stress and changes in health behaviours.

The study also said it was also unclear to what degree current findings are explained by reporting bias, recall bias, selection bias and confounding factors, adding, more research is needed.

But there have been no negative effects on periods reported.

Dr Mosina: Many women participated in clinical trials which did not identify any negative effects of vaccination on the menstruation cycle.

Additional evidence confirming safety of vaccines with regards to menstruation came from national and global vaccine safety monitoring systems after vaccination programmes were rolled-out.

Dr Mosina: People are very cautious when there is something new for them, especially when new vaccines become available.

It is understandable. WHO is striving to provide all information to address peoples concerns and help them better understand the benefits and risks of vaccination and make informed decisions on getting the vaccine.

Dr Mosina: Vaccine misinformation can have negative effects on peoples decisions to get vaccinated.

It is crucially important that not just pregnant women but everybody have access to trusted and evidence-based information.

The role of health authorities, immunisation experts and health agencies in providing this information is crucial. Media also has a major role to play in this. It's extremely important that journalists get the information from reliable sources and help deliver it.

Original post:

Do COVID vaccines affect pregnancy, fertility or periods? We asked the World Health Organization - Euronews

Temple University has set an Oct. 15 deadline for all students, faculty and staff to be fully vaccinated against COVID-19.

The announcement came after the City of Philadelphia implemented a new mandate stating all health-care workers, faculty and students of local colleges and universities need to be fully vaccinated or wear masks while indoors and get tested for COVID-19 at least once per week.

Temple athletics is required to follow university policies, which means all student-athletes and coaches are obligated to receive the vaccine unless they have a medical or religious exemption. Athletes and staff are about 80-85% vaccinated at the moment, said Kevin Addison, Temples associate director of athletic training. A mask mandate also will apply to all athletes when indoors.

While Temples athletic trainers continue to educate athletes and staff on the benefits of the vaccine, those who remain unvaccinated will abide by Philadelphia, NCAA and AAC COVID-19 procedures.

That education process started in earnest last season when players were required to have a nose swab and health check-in before class as part of their daily routine. It continued when they arrived to campus for training camp and received a single polymerase chain reaction or nucleic acid amplification test within five days of arrival.

READ MORE: Villanovas Jay Wright loved his Team USA mens basketball Olympic experience but it wasnt always fun

This year vaccinated athletes will only receive testing if they show symptoms or have a documented close contact, according to the NCAA. But unvaccinated players will receive a PCR test three days before competition or an antigen test within one day of competition. If a community spread is substantial or high, those athletes will take a weekly polymerase chain reaction test or an antigen test three times a week.

[Philadelphias] city guidance right now is three times a week that they have to be tested, and the university is two times a week when youre coming onto campus, said Jessica Reo, executive senior associate athletic director. Right now, our non-vaccinated people are getting tested three times per week.

Temples athletic trainers handled testing last season, monitoring health and positive cases for all student-athletes. With vaccination rates going up, the athletic department will now shift that responsibility and utilize on-campus resources for unvaccinated players who need testing.

With the number of student-athletes that we have that are vaccinated, and the staff that we have that are vaccinated right now, Reo said, weve been able to redirect some of that tracking and stress into care for our student-athletes.

Addisons staff met with Temples athletes in the spring and left them with a piece of paper providing background information on vaccine availability.

In early August, Addisons staff emphasized hygiene and social distancing in talks with athletes, and reminded them to avoid compromised situations.

We were able to kind of keep track of the percentage of each team that was vaccinated and we will reach out to those people who arent vaccinated, Addison said, because they know whats going on in the city is required.

The NCAA and AAC will maintain the same quarantine procedures, but if a vaccinated athlete comes in contact with a positive person theyll continue practicing.

They will have to be tested within three to five days of that exposure, so then they still can practice, they should be masked at all times other than when theyre practicing, Reo said If they are positive, then they go into isolation, just like normal, and they have to be in isolation for 10 days.

Reo said the goal is for student-athletes to take the initiative and communicate with their coaches if they arent feeling well.

Temple athletics motto was flexibility last season, and although restrictions are loosened, the school is still deciding what theyll do if athletes arent vaccinated by the deadline without an exemption. Loss of access to university buildings, suspension or expulsion are all possible risks, senior associate athletic director Lee Roberts said.

Anyone who is not vaccinated will be required to be tested, whether they have a medical or religious exemption, Reo said. Theyre still going to have to be tested regularly if theyre not vaccinated.

Traveling restrictions are another underlying area of concern for unvaccinated coaches and students, whose ability to fly with the team during competition could be affected.

Our kids all travel together, on an airplane and then on the bus, Roberts said. You know who youre traveling with, but theyll have to go back to wearing the mask as needed.

Fans who wish to attend indoor events will be required to wear a mask for entry and be asked to socially distance.

We will probably encourage people to spread out rather than sitting in a cluster, Roberts said. We have the capacity for more than 3,000, so people are more than welcome to spread out.

Outdoor sports, like field hockey and soccer, will not require fans to wear masks in the stands, but Lee could see the protocols changing as proof of vaccination is not currently required.

Temple football will follow the Eagles protocols during home games, which will require fans and stadium staff at Lincoln Financial Field to wear masks in indoor spaces regardless of vaccination status.

We are just trying to limit how much contact you have with people because you dont want to go around asking everyone, Are you vaccinated? Lee said. What we try to do is create some distance, which allows the student-athletes to play their event and also for fans, friends, family to still be able to enjoy the event.

Read more:

Temple athletics staffers share their plans for COVID-19 vaccinations, testing and more - The Philadelphia Inquirer

Worried about potential side effects of the COVID-19 vaccine? Are you unsure what activities are safe following vaccination? Whether youre vaccinated or not, AL.com will be reaching out to public health experts to get your concerns addressed about the COVID-19 vaccine.

Just send an email to vaccines@al.com and well get an expert to directly answer your question.

Here are the questions we have been able to answer for readers.

Vaccinations to protect from COVID-19 have grown in importance with the rise of the delta variant and surging infection numbers and hospitalizations across Alabama. We are taking your questions about the vaccines and getting answers from healthcare experts.

To get some answers, we consulted Rachael Lee, M.D., infectious disease physician, UAB. It should be noted that specific questions about your own health should be addressed with your primary care provider.

Question: We read about people being treated for COVID-19 who ask for the vaccine and are told its too late. Why is it too late? Wouldnt giving them the vaccine help as a treatment?

Lee said the vaccine is not a treatment for COVID-19, but a preventative measure. Once the active infection begins, a vaccine would not be helpful.

There are various therapeutic measures that physicians use to treat active COVID, Lee said. Once recovered, a patient could get the vaccine to help prevent another infection.

How long does someone have to wait? Dr. Jeanne Marrazzo, UAB director of the division of infectious diseases, said once your symptoms are resolved and you no longer feel ill, you can get the vaccine. There is no need to wait any specific number of days.

Question: I am fully vaccinated (Pfizer in Jan 2021), but have a newborn who obviously is not. I return to work next week in the medical field from parental leave. I am becoming increasingly worried about bringing COVID home asymptomatically given the rise in Delta variant cases and reports of vaccination protection waning. I intend to get a booster ASAP, but with these not yet available, what additional steps can I take to reduce the risk of me accidently introducing COVID to her?

For this question, we consulted Benjamin Estrada, who leads the department of pediatric infectious diseases at USA Health and Dr. Haidee Custodio, a pediatric infectious disease physician who sees patients at USA Health Childrens & Womens Hospital.

Here are some other things you can do to prevent the spread of COVID.

Here is more information on COVID vaccines from the Centers for Disease Control and Prevention.

See more here:

Why cant someone get the COVID-19 vaccine when theyre sick? - AL.com

Johnson & Johnson said Wednesday that a second shot of its COVID-19 vaccine eight months after the initial dose was found in a study to increase people's immunity to the disease.

The drugmaker has been testing the efficacy of boosters in people who were previously injected with its single-dose vaccine. The latest findings show that individuals who received an additional shot saw a ninefold increase in antibody levels, according to J&J. The company said researchers observed a "rapid and robust" increase in antibodies in people ages 18 to 55 and in those 65 years and older who received a lower booster dose.

While the company's single-shot vaccine stimulates a strong immune response, "With these new data, we also see that a booster dose of the Johnson & Johnson COVID-19 vaccine further increases antibody responses among study participants who had previously received our vaccine," said Dr. Mathai Mammen, global head of research and development at Johnson & Johnson's Janssen Pharmaceuticals, in a statement.

"We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson COVID-19 vaccine, boosting eight months or longer after the primary single-dose vaccination," he added.

J&J said it is working with the Food and Drug Administration, U.S. Centers for Disease Control and Prevention, European Medicines Agency and other health agencies on rolling out booster shots.

The Food and Drug Administration announced Monday that it hasgranted full approval to Pfizer and BioNTech for theirCOVID-19vaccine to be given to Americans as young as 16.

Roughly 13.8 million Americans have received J&J's coronavirus vaccine. Although studies suggest that the degree of immunity conferred by the Pfizer and Moderna vaccines fades over time, those studies have excluded J&J's shot.

Yet several studies ranging fromantibody researchthat has yet to be peer-reviewed to anecdotal reports ofmore hospitalizationsin outbreaks among vaccinated people have raised concerns that J&J's vaccine offers weaker protection to the highly contagious Delta variant.

The White House said last week that Americans who received Pfizer and Moderna shots should get booster shots eight months after their second dose, and at the same time advised that J&J vaccine recipients would eventually also need an additional shot.

With the Delta variant ravaging large swaths of the southern U.S. and COVID-19 cases rising in other states, more employers and government entities are moving to require that workers get vaccinated. Attorneys say the FDA's approval of the Pfizer-BioNTech vaccine this week will likely spur many businesses to mandate vaccines.

See the rest here:

Johnson & Johnson says booster shot of its COVID-19 vaccine strengthens immunity - CBS News

Vaccine mandates, with medical and religious exemptions, had been popping up at companies and universities even before the FDA granted full approval to Pfizer-BioNTechs coronavirus vaccine this week. But that announcement knocked down one of the anti-vaxxers main lame excuses Its an experimental drug! and paved the way for corporations, venues, restaurants and schools to more comfortably require proof of vaccination.

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Column: COVID-19 vaccine mandates are coming. The willfully unvaccinated are about to see their world shrink. - Chicago Tribune

One frequently heard pushback against vaccine mandates is that there is a "constitutional right" to choose whether to be vaccinated or not for adults and a right to determine whether children can be vaccinated. That is a non-starter in the midst of a pandemic.

The Constitution is not a suicide pact guaranteeing a right to harm others. The government has latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear.

We agree, but also believe that the public needs to better understand that there is no constitutional right to avoid vaccine mandates against a deadly disease.

Those challenging the government mandates are likely to invoke their rights under the First, Fifth, and Fourteenth Amendments, which protect speech, religion, and a right not to "be deprived of life, liberty, or property, without due process of law." Their view ends up as a snapshot of themselves; nonetheless, rights can be limited if a person is endangering another.

The government may prohibit otherwise constitutionally protected conduct to save the lives of others.

For example, it is well-settled that governments can ban yelling "Fire" in a crowded theater, because such speech can lead to death as attendees race to the exits. True, the First Amendment's Speech Clause protects the "freedom of speech," but there is no requirement that the government can't prevent scenarios likely leading to death.

The same reasoning applies to vaccine mandates. The Supreme Court explicitly upheld vaccine mandates against deadly diseases in Jacobson, where it explained: "the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand." We live in a country of ordered liberty, not individual autonomy that paves the way to the deaths of others. In short, it is not the right of every American citizen to catch and transmit a potentially fatal infection.

The depth of the science and the worldwide experience show plainly that vaccination is the best protection from this pandemic, and that the faster we reach herd immunity the more likely it will be that people won't die from this virus, hospitals won't be overburdened, and the economy will fully recover.

Children and adults have a constitutional right to "life" that can only be protected if there is mass vaccination. It's time for state and local governments to issue vaccine mandates and fines -- as New York and San Francisco have -- before this virus mutates into an even more elusive killer than it already is.

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You do not have the 'constitutional right' to refuse the Covid-19 vaccine - CNN

View Full Press Release (PDF)

The Monroe County Department of Public Health has set up an appointment reservation system for immunocompromised individuals who qualify for a third dose of Moderna or Pfizer COVID-19 vaccine. Third dose vaccines are available at all Monroe County vaccine clinics.

Eligible individuals are strongly encouraged to make an appointment through the online reservation system or by calling the COVID-19 Hotline at (585) 753-5555. While walk-ins are also welcome, the wait times may be longer without an appointment.

MAKE AN APPOINTMENT HERE:www.monroecounty.gov/healthcalls/vac/form/extra

FIND A LIST OF MONROE COUNTY VACCINE CLINICS HERE:www.monroecounty.gov/health-covid19-vaccine

MCDPH recommends individuals contacttheir healthcare provider about whether getting an additional dose is appropriate for them at this time.To receive a third dose, individuals must have received their second dose at least 28 days prior to getting an additional dose, and meet one or more of the following criteria:

Follow this link:

Department of Public Health Offering Third Dose COVID-19 Vaccines to Eligible Individuals | Monroe County, NY - monroecounty.gov

For Immediate Release: August 23, 2021

Espaol

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

The FDAs approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDAs rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product, said Acting FDA Commissioner Janet Woodcock, M.D. While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Todays milestone puts us one step closer to altering the course of this pandemic in the U.S.

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agencys standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturers submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDAs standards for approval.

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individuals genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnatys safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities, said Peter Marks, M.D., Ph.D., director of FDAs Center for Biologics Evaluation and Research. We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.

To support the FDAs approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.

Specifically, in the FDAs review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

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The FDA, an agency within the U.S. 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. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA Approves First COVID-19 Vaccine | FDA - FDA.gov