Q: The Reissued Loa Also Mentions That Changes Pertaining To Safety Monitoring Were Made To The Fact Sheet For Healthcare Providers Administering Vaccine Vaccination Providers And The Fact Sheet For Recipients And Caregivers What Were These Changes
A: The Administering Vaccine was updated to include in the Warnings section reference to guidelines from the Centers for Disease Control and Prevention for monitoring Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions. This is in addition to the warning that appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine. Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of the clinical trial setting.
The Fact Sheet for Healthcare Providers Administering Vaccine was also updated to instruct vaccination providers to provide information about v-safe to vaccine recipients. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination.
Q: Does The Fda Foresee Any Instance In Which A Vaccine Might Receive An Eua And Not Meet The Criteria For A Biologics License Application If A Product Doesnt Meet The Bla Standard Does The Eua Get Revoked
A: If safety or effectiveness concerns arise with a vaccine under EUA, FDA has the authority to revoke the EUA. However, it is expected that the data supporting the EUA, together with those that will be collected during use of vaccine under EUA, and additional data collected from ongoing trials will be sufficient to support licensure of a vaccine authorized under EUA.
The Vaccine Injected During The Booster Is Often Identical To The First But Not Necessarily: When The Targeted Virus Is Known To Evolve Rapidly Its Vaccine Must Be Modified Regularly In Order To Adapt To It
The increasing prevalence of new variants of the coronavirus raises more and more questions about the level of protection even after vaccination: won’t these changes in the SARS-CoV-2 virus escape the immunity obtained? The microbiologist and specialist in infectious diseases William Petri, of the University of Virginia, answers the most frequent questions about vaccines and their recall in 6 points.
We Don’t Talk About Herd Immunity For Protection Against Influenza Or Other Common Viral Infections So Why Is It Discussed So Much With Covid
Herd immunity is a concept used in public health to describe a situation in which the more people in a community immune to a particular pathogen, the fewer people available for that pathogen to infect. As the infectious agent spreads through a community, it has more trouble finding susceptible people if most of those around them are immune. In this manner, we rely on herd immunity for viruses, such as measles, rubella, polio, and chickenpox, among others, even if we are not having conversations about it. Influenza is more difficult because the virus changes so much from one year to the next and as such, vaccination does not offer long-term protection.
Related to COVID-19, herd immunity has been discussed more frequently for a couple of reasons. First, because this is a completely new virus, no one had pre-existing immunity. People can become immune to SARS-Co-V2, the virus that causes COVID-19, in two ways — through disease or through vaccination. By monitoring how many people are immune relative to the entire population, public health officials can offer informed guidance related to easing restrictions meant to stem spread of the virus.
Herd immunity can only be induced by vaccination. Never in history has any virus infection been eliminated because of immunity induced by natural infection.
Q: Must Vaccine Providers Give A Hard Copy Of The Authorized Recipient And Caregiver Fact Sheet To The Individual When They Get Their Shot
A: The EUA requires vaccination providers, prior to the individual receiving the vaccine, to communicate to the recipient or their caregiver information consistent with the “Fact Sheet for Recipients and Caregivers,” and either to provide a copy of the or to direct the individual to the website to obtain the Fact Sheet.
Q: Why Did Fda Revise And Issue A New Loa When The Agency Already Posted Information About The Potential For Extra Doses In The Vials
It is not uncommon for FDA to update a LOA when new information regarding an authorized product becomes available and such a revision is appropriate to protect the public health or safety. As noted, there were several updates to the LOA, and the agency reissued the updated LOA in order to provide transparency about the EUA. There are no changes to the agency’s determination that the vaccine’s known and potential benefits outweigh its known and potential risks.
Why Is The Vaccine Only For Adolescents 12 And Over When Do You Expect Vaccines To Be Available For Younger Children
Vaccine trials and approvals commonly begin with older, more vulnerable populations then extend to younger ages. Adolescents were the next group to be prioritized because they are most similar to adults and are more likely than younger children to spread the virus and become seriously ill.
Both Pfizer and Moderna have ongoing clinical trials in people younger than 12. Depending on the outcome of those trials, authorization for additional groups could happen later this year.
Is The Sept 20 Start Date For Boosters Realistic What Do Federal Agencies Have To Do To Approve This Before Then
The FDA could take multiple approaches to OK’ing the boosters, former agency officials say. It could first grant a full approval to Pfizer or Moderna for two doses and then issue an emergency use authorization for a booster dose, for instance. Or it could delay granting full approval and ultimately grant it later for two doses and a booster.
Either way, if the FDA follows its usual protocol, the agency would first convene a meeting of its outside advisory committee, as it did when it originally granted emergency use authorization for each COVID-19 vaccine.
“We know in sort of the heat of the moment, and when we’re all dealing with a real public health emergency, it becomes almost doubly important that we continually reassess and have the normal processes in place,” says Dr. Jesse Goodman, a professor at Georgetown University’s School of Medicine who used to be the chief scientist at FDA.
Goodman says he worries that setting a start date for a booster program before the relevant data can be evaluated through the normal federal processes may put “the cart before the horse.”
The committee of outside experts typically hears presentations from the government, the product manufacturer and the public. Then, it often votes on whether the FDA should give a given product the green light. The agency doesn’t have to follow the committee’s advice, but it usually does.
Does An Employee Or Student Who Tested Positive Need To Take Another Test Before Returning To Work Or School
Employees and students who have tested positive for COVID-19 and completed their isolation period should not take another COVID-19 test for 90 days because of the possibility of a false-positive result. An individual who has recovered from COVID-19 may have low levels of virus in their bodies for up to 3 months and may continue to test positive although they are not contagious. After completing the isolation period and receiving clearance from the Community Engagement team, students/employees should return to work or school.
More information is available here:
Inside Project Onyx: How Biogen Used An Fda Back Channel To Win Approval Of Its Polarizing Alzheimers Drug
Deciding to add a third shot to the Pfizer series comes with all sorts of other opportunity costs, too — including further delaying access to vaccine for low- and middle-income countries. The director-general of the World Health Organization, Tedros Adhanom Ghebreyesus, was highly critical Monday of Pfizer’s push for boosters, stressing health workers and older adults in countries without access to vaccine must be a higher priority than people who are already fully vaccinated.
“There are scientific issues. There are ethical issues,” said John Moore, an immunologist at Weill Cornell Medicine. “What is the priority? In America, at the moment, it’s getting doses 1 and 2 out to as many people as possible, particularly in undervaccinated regions. … And a booster for people who got their vaccine less than six months ago doesn’t seem to be on the same degree of urgency.”
Why Are Employees And Students Being Asked To Take A Test Within 14 Days Of Their Return To A School Site
All employees and students, regardless of vaccination status, are required to take a baseline test within 14 days of returning to their school. Baseline testing will help determine the prevalence of the virus in the school community and will prevent anyone with a positive test from entering a campus.
What We Know And Dont Know About The Need For Booster Shots Including How Often We Might Have To Get One
U.S. health authorities said people 18 years and older who got the Pfizer Inc. or Moderna Inc. Covid-19 vaccine should get an extra dose eight months later. The booster, the authorities said, may help extend the protection conferred by immunization, and help fight contagious variants like Delta, though much remains uncertain.
The FDA must authorize the extra dose before it can be offered, but is expected to do so before Sept. 20, when health authorities said boosters would become available. The agency had already authorized the additional shot for certain people with weakened immune systems. Here is what we know and don’t know about the need for boosters.
What is a booster shot?
It is the same dose as given in the two-shot regimen. The extra dose mobilizes your body’s immune system defenses further to protect against Covid-19, especially variants such as Delta that are better at eluding vaccine-generated protection. Pfizer and partner BioNTech SE said early testing indicates a booster shot given at least six months after the second vaccine dose produces antibody levels five to 10 times higher than after two doses.
Should I get a booster shot?
What Is The Testing Process For Employees And Students Who Have Made An Appointment At A Stationary Site
The testing process is simple. You can make an appointment at dailypass.lausd.net, using a phone or computer , at one of the many schools where testing is being provided. You can also call the Family Help Desk to make an appointment at 443-1300.
There’s a quick check-in upon arrival at the testing site and a clinician will be there to help oversee the process.
All results are kept confidential and stored in a separate, secure database. Information will be shared only with the appropriate scientists, administrators and health authorities.
Could The Mrna Vaccines From Pfizer And Moderna Cause The Same Clotting Problem As The J&j Vaccine Did
The Johnson & Johnson /Janssen COVID-19 vaccine is an adenovirus vector vaccine, which is different from the Pfizer and Moderna mRNA vaccines. At the time of the J&J/Janssen pause, more than 182 million doses of the mRNA vaccines had been administered and no cases of thrombosis with thrombocytopenia syndrome, or TTS, had been reported. Three people out of about 85 million doses of Moderna had blood clots, but they did not have low platelets. The number of blood clots experienced by those who got the Moderna vaccine would be expected based on the background rate of clotting in the general population.
What Is The Difference Between Emergency Use Authorization And The Normal Process Of Vaccine Approval
The main difference between emergency use authorization, or EUA, and the normal process, which is via a biologic licensure application, or BLA, is how long data were collected prior to the vaccines being reviewed for use. So, when considered quite literally, the vaccines being used today will be no different than those that are being used the day after the vaccines get full approval . The reason for the shortened timeline was, of course, because of the pandemic. But, at this point, the vaccines have been given safely to millions of people and the companies have been monitoring vaccine recipients for months. As such, at this point, delaying vaccination until the vaccines get “full approval” is taking an unnecessary risk.
Some Experts Believe Boosters Will Be Necessary Soon But Not Everybody Agrees With That Assessment
If immunity does wane over time, then subsequent COVID-19 shots will be necessary. Moderna recently indicated that a third dose will be necessary to “keep us as safe as possible” through the coming winter. Pfizer has also indicated that a third dose may boost protection against the delta variant. Some countries even announced they will offer a booster to certain high-risk populations.
However, the WHO recently called for a three-month moratorium on boosters, urging health officials to focus instead on vaccinating people around the world. And the Centers for Disease Control and Prevention has indicated that boosters are not necessary now, and that it is working with other public health organizations to determine if and when they might be needed down the road. To date, research shows that the vaccines hold up well against the variants, even delta. A July study found, for example, that two shots of the Pfizer vaccine were 88% effective at preventing symptomatic infection from the delta variant.
Wolfe said in May he’d “be very surprised if it was in 2021. Beyond that, I’d be surprised if it wasn’t in 2022.”
Is There Any Hope That A Vaccine Will Help People With Lingering After Effects From Coronavirus
The lingering effects of COVID-19 are concerning, and we still have much to learn about them. A vaccine will help from the point of view that if it decreases infections, fewer people will experience illness and, therefore, fewer people will experience long-term effects. But, it is not likely that a vaccine will address these effects in someone who was already infected.
Why Should I Vaccinate My Child If Cases Are Low And Children Aren’t Severely Impacted By Covid
Vaccinating students age 12 and over is an important part of creating the safest possible environment at schools, and protects the student’s family members.
The American Academy of Pediatrics reports that in May 2021 youth accounted for 22 percent of new COVID-19 cases in the U.S., when in Spring 2020 youth cases were only around three percent. It is important to get young people vaccinated to prevent new cases from increasing, starting with our 12 to 18-year-olds.
Fauci Says That Vaccines Have Been The Key To Ending Previous Outbreaks Of Serious Disease
While this may be the first pandemic individuals under 100 have lived through, COVID is hardly the first public health crisis that will be solved with vaccines. “Throughout our history, we’ve been confronted with diseases that have threatened our health, life, and even our survival. Smallpox, measles, polio—every one of them has been conquered by vaccines,” Fauci said.
“We are fortunate that already we have three highly efficacious vaccines that have a very good safety profile. Soon, we will have even more,” he added. Now, the task at hand is to get vaccines into arms “in a very organized, quick, and efficient manner,” Fauci says. And for more vaccine tips, The CDC Says You Don’t Need to Do This Before Your COVID Vaccine.
Does The Us Have Enough Vaccine Supply To Eventually Give A Third Shot To Everyone Over 18
Yes, or at least it will. While the U.S. has plenty of vaccine doses that haven’t yet been administered, it doesn’t have enough in hand right now to give everyone a third shot immediately.
But more doses are on the way.
The United States struck deals with Pfizerand Moderna earlier this summer to purchase another 400 million doses, which are expected to be delivered starting next month — when the Biden administration says it plans to begin offering boosters — through April of 2022.
That should be enough to give all 258 million U.S. adults a third shot and to vaccinate any children under 12 who are likely to soon be eligible for vaccinations. The tens of millions of leftover shots from the first wave of purchase agreements will likely help prevent scarcity throughout the booster rollout.
It’s important to keep in mind that the administration is planning for a gradual rollout with the people who were originally vaccinated earliest going first.
“If the booster is based upon elapsed time since completion of the initial series, you wouldn’t need all the doses to be on hand,” says Hannan, of the Association of Immunization Managers. “So assessing the supply is a little complicated. But suffice to say, we have plenty of supply right now.”
Jeffrey Zients, the White House coronavirus response coordinator, says the Biden administration is “ready” for boosters.
NPR’s Allison Aubrey and Rob Stein contributed to this report.
Does A Vaccinated Person Present A Risk To Unvaccinated Family Members In The Same House
Vaccinated people do not shed virus as a result of vaccination. Neither the mRNA nor the adenovirus vaccines are composed of live viruses, so there is no infectious virus to spread from a vaccinated person to someone else.
But we do not yet know if a vaccinated person who encounters the virus can still experience what is referred to as “asymptomatic infection.” An asymptomatic infection occurs when a person is exposed to the virus in the community and the virus can still replicate in their body, but they don’t have symptoms because their immune system stifles the infection as a result of vaccination. In this scenario, the person could potentially spread the virus without even knowing they are infected. While it is not anticipated that vaccinated individuals will be likely to spread the virus even if they experience asymptomatic infection, this has not yet been shown to be the case. Therefore, we need to practice caution until we know for certain.
Given that families and friends will not all be vaccinated yet, vaccinated individuals should continue to follow public health guidance when they are out in the community to decrease the chance of introducing the virus in the home through asymptomatic infection. Likewise, even when a whole family is vaccinated, continuing to practice these measures will be important for two reasons:1. The vaccine will not work for everyone, so someone in the home who has been vaccinated may still be susceptible.
Will The Spike Protein From Current Vaccines Cause An Issue If There Are Future Variants
This question has two aspects – longevity of the spike protein and effects of current immune responses to future variants. While related, these are not cumulative issues, meaning they involve separate considerations:
- Longevity of the spike protein – The spike protein does not remain in the body for an extended time, nor does it travel around the body. The only thing that remains after the vaccine is processed are antibodies and memory immune cells that will recognize the virus if we are exposed in the future. The antibodies and memory cells will or will not recognize the variant spike protein. If they do, great – we will have some protection. If they don’t, it will be just like an antibody to flu or measles, it will have no effect.
- Effects of current immune responses to future variants – As the virus evolves, it changes, so we might find ourselves dealing with different versions of the virus in the future. Current variants have not changed significantly enough that our antibodies have stopped being protective, so for now, we do not need additional doses of vaccine. If, however, one of these variants changes enough that the vaccine-induced immunity is no longer protective, we will need to make new COVID-19 vaccines that protect against the new version of the virus. As described above, in this scenario the existing immunologic memory will no longer be effective, but it will not be problematic either. A new vaccine would induce new immunity and the process would begin anew.
Is Los Angeles Unified Working With The Los Angeles County Department Of Public Health
Los Angeles Unified has consulted with the Los Angeles County Department of Public Health on all aspects of the testing program. Regulations require all positive cases to be reported to the department, which in turn is involved in the formal contact-tracing process for Los Angeles Unified employees or students who test positive for the virus.
I’m Not Immunocompromised Why Can’t I Get An Additional Covid Vaccine Shot Right Now
For about 97% of vaccinated Americans, you don’t need it yet.
Vaccinated people with healthy immune systems are still well-protected and should not be getting another shot just yet.
Studies have found the three vaccines available in the United States – Moderna, Pfizer-BioNTech and Johnson & Johnson – all remain effective against the delta variant, although reports are starting to come in of a drop-off in effectiveness after time.
“The vaccine is effective at preventing severe illness regardless of what the strain is,” said Dr. David Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, New York.
It is far more important to get unvaccinated people vaccinated, and for people who have only received one of the two required doses of the Pfizer or Moderna vaccines to get their second dose. The best defense for immunocompromised people is to be surrounded by people who are vaccinated.
Prenatal Tests Developed By The Chinese Military Being Used To Collect Personal Data
A test taken by millions of pregnant women around the world, which has been developed in collaboration with the Chinese military, is being used to collect genetic data without the women’s consent, according to an investigation by Reuters.
The prenatal blood test, developed by the Chinese BGI Group, is offered to millions of pregnant women to screen for abnormalities such as Down Syndrome in early pregnancy. It is used in at least 52 countries including the UK, other countries in Europe, Canada, Australia, Thailand and India, but not the United States.
BGI uses leftover blood samples sent to its laboratory in Hong Kong and genetic data from the tests for population research, the company confirmed to Reuters. Reuters found the genetic data is then stored at the government-funded China National GeneBank in Shenzhen, which BGI operates.
The US government has expressed grave concerns that the amassing of such data could give China an economic and military advantage in the future. Science has shown us that there are proven links between genes and certain human traits, and having access to such large quantities of genetic information could theoretically pave the way for China to genetically engineer human traits in people in the future or even genetically modify bacteria and viruses to affect people in different ways.
If I Get A Coronavirus Vaccination Do I Still Have To Wear A Mask Physical Distance
The CDC continues to monitor the spread of COVID-19 and makes recommendations for wearing face masks, both for those who are fully vaccinated as well as those who are not fully vaccinated.
The CDC also recommends that masks and physical distancing are required when going to the doctor’s office, hospitals or long-term care facilities, including all Johns Hopkins hospitals, care centers and offices.
Johns Hopkins Medicine’s current mask safety guidelines have not changed, and we still require all individuals to wear masks inside all of our facilities.
If A Person Has Allergic Reactions To A Food Or Medication Can They Get The Vaccine
People with severe allergies to a COVID-19 vaccine ingredient or a previous dose of COVID-19 vaccine should not get that type of COVID-19 vaccine . They may be able to get the alternative type after consultation with an allergist or immunologist. Individuals with a known allergy to polysorbate should not get the COVID-19 vaccine made by Johnson & Johnson/Janssen.
People with immediate allergic reactions to an injectable medication can most often get the COVID-19 vaccine; however, they should remain at the site where they were vaccinated for 30 minutes of observation, instead of the 15 minutes that the general public is recommended to wait. Anyone with this type of allergy who has questions or concerns should discuss the situation with their healthcare provider to assess the potential risks and benefits of receiving the COVID-19 vaccine.
People who have had an anaphylactic reaction to anything else are allowed to get the COVID-19 vaccine, but should remain at the site where the injection was given for 30 minutes, instead of the 15 minutes that the general population are recommended to wait.
If a person with history of allergies continues to have concerns about whether or not it is safe to get the COVID-19 vaccine, they should contact their primary care provider or allergist, who has the benefit of their complete medical history and will, therefore, be in the best position to discuss any potential risks and benefits for that individual.