Vaccine Clinical Trial Process
Phase one: Checks the safety of a vaccine and determines whether it triggers an immune response in a small group of healthy humans.
Phase two: Widens the testing pool to include groups of people who may have the disease or be more likely to catch it, to gauge the vaccines effectiveness.
Phase three: Expands the pool up to the thousands to make sure the vaccine is safe and effective among a wider array of people, given that immune response can vary by age, ethnicity, or by underlying health conditions.
The COVID-19 candidates, like all vaccines, essentially aim to instruct the immune system to mount a defense, which is sometimes stronger than what would be provided through natural infection and comes with fewer health consequences.
To do so, traditional vaccines use the whole coronavirus, but in a killed or weakened state. Others use only part of the viruswhether a protein or a fragment. Some transfer the instructions for coronavirus proteins into an unrelated virus that is unlikely or even incapable of causing disease. Finally, cutting-edge vaccines under development rely on deploying pieces of the coronaviruss genetic material, enabling our cells to temporarily make coronavirus proteins needed to stimulate our immune systems.
How Safe Is The Covid
Paul Offit, MD, a member of the FDA advisory panel that recommended the vaccineâs use, says rigorous clinical trials of the shot identified no safety concerns, despite its sped-up production.
âThese vaccines were subjected to large phase III clinical trials,â says Offit, a vaccine expert at Childrenâs Hospital of Philadelphia. âRegarding safety, there was an insistence by the FDA that at least tens of thousands of people be observed for 2 months after the final dose to make sure that there were no â¦ uncommon side effects.â
Offit says the fast-tracking of the vaccine was mostly a result of the upfront financing the federal government provided, so no shortcuts were taken in verifying its safety.
âThe government essentially paid for overlapping phenomena, which is to say the vaccines were mass-produced without knowing if they worked or were safe yet, so they overlapped the phase III trials with the mass production, which would never normally happen,â he says.
Gigi Gronvall, MD, an immunologist and infectious disease specialist with the Johns Hopkins Center for Health Security, agrees and says the vaccine still underwent all of the safety checks involved in any clinical trial.
âIt has been tested as other vaccines and drugs have been. There were no things done differently, but the financial part made things happen faster,â says Gronvall, an associate professor at the Johns Hopkins Bloomberg School of Public Health.
When Can We Expect To Get Vaccinated
On March 2, President Joe Biden announced that he had ramped up production, vowing there will be enough vaccine doses so every U.S. adult could be immunized by May. Â
Paul Offit, MD, director, Vaccine Education Center, and professor of pediatrics, Children’s Hospital of Philadelphia; professor of vaccinology, Perelman School of Medicine, University of Pennsylvania.
CDC: “Vaccines: The Basics,” “When Vaccine is Limited, Who Gets Vaccinated First?” “Understanding How COVID-19 Vaccines Work,” “Meeting of the Advisory Committee on Immunization Practices November 23,” “Understanding mRNA COVID-19 Vaccines.”
JAMA: “COVID-19 and mRNA Vaccines — First Large Test for a New Approach.”
The Lancet: “Oxford-AstraZeneca COVID-19 vaccine efficacy.”
Facebook interview: Mark Zuckerberg and Anthony Fauci, MD, Nov. 30, 2020.
FDA: “Vaccines and Related Biological Products Advisory Committee Meeting, Dec. 17, 2020.”
Naor Bar-Zeev, PhD, associate professor of international health and vaccinology and deputy director, International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore.
Statista.com: “The Cost Per Jab of Covid-19 Vaccine Candidates.”
AstraZeneca: “COVID-19 vaccine AZD1222 is better tolerated in older adults than younger adults with similar immune responses across all age groups.”
Moderna: “Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study.”
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Does Cvs At 3711 E Frank Phillips Blvd Bartlesville Ok 74006 Offer Flu Shots
Flu shots are offered at the CVS Pharmacy at 3711 E. Frank Phillips Blvd. Bartlesville, OK 74006. Schedule your flu shot ahead of time so you can get in and out faster. Provide your insurance information and answer questions online ahead of time. Find more flu shot FAQs and other flu vaccination resources.
Side Effects And Adverse Events
No serious adverse events were reported in early trials of the Novavax vaccine, but more information will be available after the late-stage trial results are published. In Phase 3, adverse events “occurred at low levels and were balanced between vaccine and placebo groups.” according to Novavax.
The most common side effects, according to Novavax:
- Injection site pain and tenderness
- Muscle pain
Injection site pain lasted less than three days and fatigue, headaches, or muscle pain lasted less than two days in the Phase 3 trials.
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World Briefs: Protest In Berlin New Zealand Extends Lockdown Fauci Backs Vaccine Mandate
Via the Reuters news agency:
An increase in COVID-19 transmission rates across Europe over the last two weeks combined with low levels of vaccination in some countries are deeply worrying, head of the World Health Organization in Europe Hans Kluge said.
A third-dose booster shot of the vaccination is a way to keep the most vulnerable safe and not a luxury, he added.
- Several thousand people marched through the streets of Berlin on Sunday for a second day of unauthorized protest against vaccinations and restrictions aimed at curbing a fourth wave of the pandemic.
Walmart Says Ready To Administer Millions Of Covid
A person waits at a Walmart Pharmacy where the Moderna coronavirus disease vaccine is available as Walmart and other major U.S. pharmacies take part in the Federal Retail Pharmacy Program, to increase vaccinations in the U.S. in West Haven, Connecticut, U.S., February 17, 2021. REUTERS/Mike Segar
Aug 31 – Walmart Inc on Tuesday became the latest U.S. retailer to say that it is ready to administer millions of COVID-19 booster vaccine doses this fall if U.S. health officials endorse such a shot to improve fading immunity against the coronavirus.
Rivals CVS Health Corp and Kroger Co earlier this month had announced plans to make booster shots available at their stores, pending regulatory guidance. read more
U.S. health regulators have authorized a third dose of the vaccines made by Pfizer and partner BioNTech as well as Moderna for those with weak immune systems, and the government has said it plans to make booster doses available to more Americans in September.
The need for boosters, however, has not yet been recommended by health regulators.
The U.S. Centers for Disease Control and Prevention on Monday said it may be difficult to determine at this point whether immunity from prior vaccination is waning over time or if the vaccines are just less able to prevent infection by the highly-transmissible Delta variant. read more
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Have There Been Any Covid
Issues concerning the Johnson & Johnson COVID-19 vaccine and a rare incidence of myocarditis after the Pfizer and Moderna COVID-19 vaccines, as noted above have been reported.
Trials for the vaccines have had fully independent safety monitoring boards, and safety data are continuously reviewed by the FDA and expert panels. The number of serious problems in test participants was very low, and there was little difference between those who received the actual vaccine and those who received a placebo. Millions of people have received the vaccines since their authorization, and careful safety monitoring of all three COVID-19 vaccines continues.
Is There Risk Of Allergic Reaction From Covid
According to the CDC, anyone who has a known severe allergy to any of the vaccine ingredients should not receive that vaccine.
The CDC says people with allergies to certain foods, insects, latex and other common allergens can safely receive the COVID-19 vaccine. Those with a history of severe allergic reaction to injectables or other vaccines should discuss the vaccination with their doctor, who can evaluate and assess their risk.
How Do We Know a COVID-19 Vaccine Will Be Safe and Effective?
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Who Is Receiving The Covid
When the first two vaccines received authorization from the FDA in December, the CDC released initial guidelines, which recommended vaccinations first for healthcare workers and long-term care patients, then essential workers and those 75 and older, followed by people in high-risk groups and those 65 and older.
But because the federal government is distributing vaccine doses directly to states, its up to each one to decide how to get them to citizens. In other words, there are 50 different distribution plans, and your eligibility might look strikingly different than that of a relative across the country.
If youre a member of an eligible group in your state, your healthcare provider has likely already contacted you, says Andrew Thomas, M.D., chief clinical officer at The Ohio State University Wexner Medical Center, who was instrumental in building Ohios vaccine signup infrastructure.
Many health systems have been contacting anyone in their records who meets their states vaccine eligibility requirements, although this isnt guaranteed. Once contacted, patients can schedule an appointmentagain, this varies by state, but sign-ups are often conducted via the state health departments website or over the phone with an operator. Nearly all clinics require appointments to ensure there are enough doses, so solidifying your time slot is crucial.
Do Kids Need The Vaccine When They Haven’t Been Affected By The Virus As Much As Adults
According to doctors at Advocate Children’s Hospital, the answer is yes.
“We’ve had kids hospitalized since the beginning of the pandemic, some who have been quite ill,” Moore said. “We also in June of this past year, started to see the inflammatory syndrome that we’ve mentioned before… and those kids can be very sick down to very young ages, down to toddler ages.”
Dr. Frank Belmonte, chief medical officer at Advocate Childrens Hospital, also noted that children getting vaccinated can help prevent spread among adults as well.
“Actually, in that 12 to 18 age range, there’s about a 20% transmissibility,” he said. “So even if they don’t get, you know, really sick from the virus they can spread it to family members or to other vulnerable folks in their community.”
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When Will Kids Get Covid Vaccines
Pharmaceutical companies are starting clinical trials in young children and adolescents, but they must balance speed and safety
As adults around the world scramble to get vaccinated against COVID-19, pharmaceutical companies are turning their attention toward one quarter of the population that still has no available shots: kids.
Several pharmaceutical companies are doing clinical trials in adolescents or young children. Pfizer was already testing its vaccine in kids aged 12 to 15, and it just announced results showing that its vaccine works very well at preventing COVID in this age group.* Moderna has been testing its vaccine in those aged 12 to 17. And this month bothcompanies began trials in children aged six months to 11 years. Johnson & Johnson recently described plans to test its vaccine in young children and adolescents, too.
The upshot of such findings is that the U.S. must inoculate kids if it ever wants to reach herd immunity. If we think about the fact that 18 and under actually make up 25 percent of the population of the United States and probably a bigger proportion of the world population, we really need to make sure that children are part of the population that are immune by vaccine, says Yvonne Maldonado, a pediatric infectious disease physician at the Stanford University School of Medicine and chair of the American Academy of Pediatrics Committee on Infectious Diseases.
In Particular Vaccine Researchers Are Studying The Best Dosage For Each Age Group
In all of the clinical trials above, the vaccines are identical to the versions that adults receive, but theyre given at kid-sized doses. To determine the best dosage, clinical trials are broken into age groups for different stages of a childs growth and development.
For example, Pfizer is running separate trials for its COVID-19 vaccine in ages 5 to 11, ages 2 to under 5, and ages 6 months to under 2 years. All age groups are receiving the same vaccine, but the size of the dose might be different. Typically, the younger the age group, the smaller the dose.
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Fauci: It Is Important People Get Their Second Covid Vaccine Dose ‘on Time’
Gorskys remarks came two days after Dr. Anthony Fauci, the nations leading expert on infectious diseases, said during a White House briefing that its vitally important to stay ahead of the mutant variants of Covid-19.
Fauci and other scientists believe the coronavirus has undergone thousands of mutations since it was first detected in humans. While most ended up being inconsequential, the experts are concerned about any alterations that could make the virus more contagious or make the available vaccines less effective.
Summer Johnson McGee, who is dean of the University of New Havens School of Health Sciences, said it remains to be seen whether Covid-19 vaccination will be needed annually or whether we will need booster shots for new variants each year.
But she instead stressed that the system for distributing vaccines in the United States needs to be updated so that we are prepared for yearly boosters.
We need to plan and prepare our health care infrastructure and the public to engage in mass vaccination every year, McGee said. We need to learn how we can do mass vaccination more efficiently and with greater participation so that, if this becomes an annual process, we can achieve our vaccination targets much more easily and faster.
I think, in general, much of the public has been accepting of the vaccine, he said. We are already starting to see the benefits. Here in Connecticut we are starting to see a decline in new cases.
When Can We Expect A Vaccine For Kids Under 12
Pfizer does not have a definitive date for when a vaccine for children under 12 will be released.
The company said it anticipates data to be available for children ages 5 to 11 in September and could submit for emergency use authorization soon after, Kit Longley, a spokeswoman for Pfizer, said in an email.
Cennimo said its smart to prioritize that age group first.
Theyll have more social contact in school settings than younger kids, and we would want to get protected as soon as possible, Cennimo said.
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What Happens If You Don’t Take The Second Dose
Protection is assumed to be less. In data that Moderna submitted to the FDA before its Dec. 17 review for its request for emergency use authorization, for instance, its analysis suggested that the first dose provides protection from getting COVID-19, but the data did not allow for a âfirm conclusion,” the FDA says. Both the Pfizer and Moderna vaccines are believed to be around 50% effective after just one dose.Â
What About Variants
New versions of the coronavirus are emerging in countries around the world.
However, there is a warning sign from Janssen and Novavax, which have the first “real-world” data on the new variants.
Both showed a dip in their overall effectiveness in South Africa, where a new and worrying variant has been spreading.
The results were still good and clearly better than no vaccine at all, but they emphasise how coronavirus is a moving target.
We may need to change the vaccines we use in the future.
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When Will A Covid
With the highly contagious Delta variant taking hold in communities across the country, and a new school year on the horizon, parents are eager for kids of all ages to have the protection of a COVID-19 vaccine.
There Could Possibly Be A Covid
Vaccines are usually studied and approved in order of age, with healthy adults first and babies last. After a COVID-19 vaccine is authorized for the oldest clinical trial group of kids, a company will move to the next youngest group.
Pfizer has said that once they have results from their clinical trial for 5-to-11-year-olds expected in September or October results for the 2-to-under-5 age group and 6-months-to-under-2 age group could quickly follow. They might then begin the same process for FDA emergency authorization for these ages.
Depending on how the next few months go, its possible there could be a COVID-19 vaccine for children as young as 6 months old by midwinter.
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A Vaccine Made From Coronaviruses
CoronaVac works by teaching the immune system to make antibodies against the SARS-CoV-2 coronavirus. The antibodies attach to viral proteins, such as the so-called spike proteins that stud its surface.
The researchers then drew off the inactivated viruses and mixed them with a tiny amount of an aluminum-based compound called an adjuvant. Adjuvants stimulate the immune system to boost its response to a vaccine.
Inactivated viruses have been used for over a century. Jonas Salk used them to create his polio vaccine in the 1950s, and theyre the bases for vaccines against other diseases including rabies and hepatitis A.
Weighing Risk Against Benefit
When decision time comes for the federal Food and Drug Administration, the risks of the vaccine will be weighed against the benefits of preventing COVID in the age group for which the authorization is sought.
That risk-benefit balance is different for children than adults, because children have lower odds of severe illness or death from COVID. In other words, a higher level of risk from the vaccine is acceptable for adults because they are more likely to face severe illness or death if they get infected.
Balancing that is the risk of harm from the vaccine itself. The clinical trials are limited in size and duration, however. Rare side effects that turn up when a vaccine is given to millions of people may not appear or be seen as statistically significant in a relatively small study sample.
And the application for emergency use authorization also is likely to be considered before safety data from a full six months post-vaccine are gathered for the 5- to 11-year-olds in the study.
Countering those doubts, experts offer two arguments. First, they note that the vaccine has already been used in millions of adults. Second, they point to the strong monitoring system in place to detect any problems that crop up after vaccines are put into widespread use.
And so far, the federal Centers for Disease Control and Prevention has confirmed relatively few adverse events. They are so rare, the agency has concluded, that its recommendation for vaccinating everyone age 12 and older stands.
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When Can Kids Under 12 Get The Covid Vaccine What Parents Should Know
If you have a child younger than 12, youre likely feeling stuck in a jam again as schools reopen while pediatric COVID-19 cases are surging. Adding to the anxiety is a recent Washington Post report on an alarming model that suggests 75% of students will have contracted COVID-19 within three months in elementary schools that dont adopt masking or virus testing protocols.
And though tweens and teens are eligible to be vaccinated , parents of children under 12 are still waiting. Aside from masking up and avoiding crowded indoor settings, it feels as if theres still not much that parents of younger kids can do.
So HuffPost Parents spoke with several experts about where we are in the process of getting kids under 12 vaccinated and why the process seems to be taking longer than expected.
When Will The Covid
On April 6, President Biden announced that he would direct states to make every adult in the U.S. eligible for vaccination no later than April 19, two weeks earlier than his previously announced deadline of May 1, in hopes of returning the nation to some sense of normalcy by July 4.
Depending on where you live, there might be wiggle room even before then. April will be what I would call open season, Anthony Fauci, M.D., the nations leading infectious disease expert, explained on NBCs Today show on February 11. He expects that virtually anybody and everybody will be able to sign up for and receive a COVID-19 vaccine this month.
For example, Iowa Governor Kim Reynoldswho lifted mask requirements in the state despite public health recommendationsannounced in March that anyone of-age will be able to receive the vaccine in Iowa starting April 5. and New York, meanwhile, opened up vaccine eligibility to all residents 16 and older on April 6.
Vaccine supply had already been steadily increasing before the Johnson & Johnson vaccine received approval, Dr. Thomas explains. In Ohio, he notes that the number of doses made available each week more than doubled from mid-January to the beginning of March. There are more immunization clinics now, too, run by states, hospitals, and retail locations.
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Extra Shots Are Being Weighed As A Way To Extend Protection Against The Coronavirus As Worrisome Variants Spread
The Food and Drug Administration expects to have a strategy on Covid-19 vaccine boosters by early September that would lay out when and which vaccinated individuals should get the follow-up shots, according to people familiar with discussions within the agency.
The Biden administration is pushing for the swift release of a booster strategy because some populationspeople age 65 or older and people who are immunocompromised, as well as those who got the shots in December or January shortly after they were rolled outcould need boosters as soon as this month, two of the people said.
Any booster strategy from the U.S. government will need to address declining protection for certain people at a time when vaccines remain in short supply in the developing world.
About half of the country has been fully vaccinated, or 165 million people, federal data show.
Research shows that the authorized vaccines offer effective protection against symptomatic Covid-19 for at least six months. But the protection diminishes over time, leading some public-health experts and vaccine makers to believe that boosters are necessary to maintain protection. A growing body of evidence suggests the vaccines are less effective among people with weakened immune systems than among the general population.
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.
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Can The Vaccine Cause Other Side Effects
Yes. The FDA says common side effects, in Pfizer’s clinical trial involving some 44,000 people, included pain where they got the shot, fatigue, headache, chills, fever, and joint and muscle pain. But these are all described as temporary.
The symptoms were generally mild or moderate, and happened more frequently after the second dose.
Moderna reported similar side effects in its trial of more than 30,000 people. Participants most commonly reported pain at the injection site, fatigue, headache, muscle pain, joint pain and chills.Â
âPeople should also know that less serious adverse reactions — side effects — are pretty common with this vaccine, so itâs not going to be like the flu shot, where you might just have a sore arm,â Gronvall says.
âFor a lot of people, theyâll be pretty tired, they might have a small fever, and they can have headaches. And all of these reactions are normal, and thatâs the result of your body getting ready to be able to fight off COVID.â