Appendix D: Clinical Trial Evidence Summary For Janssen Covid
Data from Phase 1, 2, and 3 trials were available at the time of authorization for the Janssen vaccine. Evidence on efficacy, immunogenicity, and safety is available for adults â¥18 years of age. The Phase 3 trial involved 44,325 study participants randomized to receive either the vaccine or placebo. The data presented below was a median of two months after the completion of the series . Evidence from post-marketing surveillance and studies is found in the main body of this statement.
Concerns About Vaccine Rollout For Kids 5
FDA officials arent required to follow the panels vote, though they often do. A CDC panel will meet next week to discuss whether to recommend vaccinating this age group.
Though the CDC cannot broaden the eligibility requirements set by the FDA, it can make them stricter.
There are high-risk individuals and I think they do need to be attended towe do need to provide a vaccine for them, Steven Pergam, MD, MP, MPH, medical director at the Seattle Cancer Care Alliance, said. He added that others should have the option to get one or no dose and they may not need anything more.”
In an FDA survey conducted through August, 37% of children aged 5 to 11 who were hospitalized for COVID-19 were Black non-Hispanic, 31% were Hispanic, and 22% were White.
Given these stark disparities, James Hildreth, PhD, MD, panelist and president of Meharry Medical College in Nashville, said he voted yes to ensure the vaccine is available to kids who really need the vaccineprimarily the Black and Brown children in our country.
H. Cody Meissner, MD, a panelist and chief of the Division of Pediatric Infectious Diseases at Tufts Childrens Hospital, said that while he voted yes, he was concerned that authorization would lead to some state governments imposing vaccine mandates for school-aged children.
I think that would be an error at this time, until we get more information about the safety, Meissner said.
Considerations For Vaccination Of People With Certain Underlying Medical Conditions
Any currently FDA-approved or FDA-authorized COVID-19 vaccine can be administered to people with underlying medical conditions who have no contraindications to vaccination ACIP does not state a product preference. Clinical trials demonstrated similar safety and efficacy profiles in people with some underlying medical conditions, including those that place them at increased risk for severe COVID-19 symptoms, compared to people without comorbidities. Additional information for people with specific underlying medical conditions is included below. Healthcare professionals or health departments in the United States can request a consultation from the Clinical Immunization Safety Assessment COVIDvax project if they have complex COVID-19 vaccine safety questions not readily addressed by CDC guidance.
People with a history of myocarditis or pericarditis
Myocarditis or pericarditis have occurred rarely in some people following receipt of mRNA COVID-19 vaccines . The mechanisms that cause myocarditis or pericarditis following vaccination with an mRNA COVID-19 vaccine are not well understood. Cases of myocarditis or pericarditis have occurred predominantly in males aged 12-29 years within a few days after receiving the second dose of vaccine. Most patients have been hospitalized for short periods, with the majority achieving resolution of acute symptoms. Follow-up is ongoing to identify and understand potential long-term outcomes among cases.
People with autoimmune conditions
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When Can I Expect To Receive My Vaccination
There is a massive global demand for COVID-19 vaccines and vaccine supply is still limited which means that not everyone will be able to get the vaccine at the same time. All countries need access to safe and effective COVID-19 vaccines and within countries the first batches of vaccines need to be given first to the people who are at highest risk of infection, serious disease, or death. This includes health workers who care for COVID-19 patients, older adults and subsequently people with certain underlying health conditions. Visit the official Government website to learn more about the national rollout plan.
Neither Moderna Nor Pfizer Enrolled Pregnant Women In Their Covid
Most pregnant women shouldnt take the Covid-19 vaccines from Moderna and Pfizer-BioNTech unless at high risk of exposure or severe illness, the WHO said.
The World Health Organization released new guidance about Moderna Inc.s Covid-19 vaccine this week, recommending generally against the use of the vaccine during pregnancy except in those at high risk of exposure or having a severe case.
In the interim, WHO recommends not to use mRNA-1273 in pregnancy, unless the benefit of vaccinating a pregnant woman outweighs the potential vaccine risks, such as in health workers at high risk of exposure and pregnant women with co-morbidities placing them in a high-risk group for severe Covid-19, the guidance said. The agency said its recommendations would be updated as more data become available.
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Why It Matters Even If You Dont Have Kids
Children ages 5 to 11 make up about 10 percent of the entire Texas population.
Their eligibility for vaccination, combined with strong vaccine acceptance among their parents, will go a long way in increasing Texas level of herd immunity and reducing the risk of children catching the virus and passing it along to compromised family members or friends, experts say.
Unvaccinated populations are also reservoirs for the virus to grow and mutate, risking new variants that could overpower the current vaccines.
People without kids often have relationships with family members or friends who do have children. Vaccinating younger children will also allow parents to go to work if they have been staying home with an immunocompromised child who was at high risk for COVID-19. By extension, a parent’s return to work benefits the economy and childless Texans.
I think this has the potential to really improve their lives, said Dr. Seth Kaplan, a Frisco pediatrician and immediate past president of the Texas Pediatric Society.
Considerations For Use Of The Janssen Covid
Thrombosis with thrombocytopenia syndrome
Thrombosis with thrombocytopenia syndrome is a rare syndrome that involves acute venous or arterial thrombosis and new onset thrombocytopenia in patients with no recent known exposure to heparin. In the United States, the majority of people with TTS that occurred after Janssen COVID-19 vaccination had clots located in cerebral venous sinuses clots also occurred in other unusual locations, including in the portal vein and splenic vein, and included a combination of venous and arterial thromboses. FDA updated the Janssen COVID-19 vaccine EUA Fact Sheetexternal icon for Health Care Providers Administering Vaccine and Fact Sheetexternal icon for Recipients and Caregivers to include information about rare clotting events that might occur after vaccination, primarily among women aged 1849 years.
Women aged < 50 years
The highest rates of TTS per vaccine doses administered were identified in women < 50 years of age. Women aged < 50 years can receive any currently FDA-approved or FDA-authorized COVID-19 vaccine. However, they should be made aware of the rare risk of TTS after receipt of the Janssen COVID-19 vaccine and the availability of other currently FDA-approved or FDA-authorized COVID-19 vaccines . At the time of ACIPs review, TTS reporting rates to VAERS were 7.0 cases per million Janssen COVID-19 vaccine doses administered to women aged 1849 years and 0.9 per million to women aged50 years.
Use of aspirin or anticoagulants
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Who Advisory Group Recommends Extra Covid
People with weaker immune systems should receive an additional shot of approved COVID-19 vaccines, an advisory group to the World Health Organization said on Monday.
The recommendation follows a four-day meeting of the Strategic Advisory Group of Experts on Immunization. A final report will be issued in December.
The Who Didnt Reverse Its Position On Kids And Covid Vaccines
By Victoria KnightJune 25, 2021
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Why Are Vaccine Clinical Trials Sometimes Paused
Safety is one of the main focuses for vaccine clinical trials. When a potentially unexplained illness occurs in a trial participant it is normal to investigate. Temporary suspensions of vaccine clinical trials are not unusual while researchers investigate what happened. Since safety monitoring continues even after the approval of a vaccine, it is not uncommon to pause the administration of a vaccine in the general population to review available data. To date, only AstraZeneca and Janssen vaccines experienced this pause, and vaccination was resumed 2-3 weeks after.
Poll Finds Lack Of Public Knowledge About Vaccines
President Joe Biden has encountered an ignorance problem in his attempts to lead the country out of the pandemic, and it’s affecting the public’s trust in his administration.
A new Axios/Ipsos poll finds Americans are uncertain about how well the COVID-19 vaccines work, despite reams of data about their ability to protect people from severe disease, hospitalization and death, and to a lesser extent infection. That lack of knowledge is likely contributing to the continued vaccine holdout of 60 million people who are eligible for the shots, and to diminished faith in the Biden administration.
Confidence that his government can make sure the economy recovers quickly after the pandemic dropped from 52% in late January to 44% in the latest poll.
Some of that eroding confidence may be rooted in how little Americans know about the vaccines, which are central to Biden’s plan for the U.S. to escape the pandemic. In the poll, only slightly more than 25% of respondents correctly said that a vaccinated 80-year-old is at greater risk of dying of COVID-19 than an unvaccinated 30-year-old. And only 40% knew that vaccinated people are less likely to test positive for the coronavirus than those who haven’t been inoculated.
Vaccination Of Children And Adolescents
Adolescents aged 1217 years are eligible to receive the Pfizer-BioNTech COVID-19 vaccine and may be vaccinated with appropriate consent and assent. Sites administering COVID-19 vaccines should follow current state/jurisdictional policies and practices for other routine immunizations in this age group.
Available safety, immunogenicity, and reactogenicity data are similar to those seen in young adults aged 16-25 years. Syncope may occur in association with any injectable vaccines, especially among adolescents. Procedures should be in place to prevent falling injuries and manage syncopal reactions. All people are recommended to be observed for 15 minutes after vaccination patients should be seated or lying down during the observation period to decrease the risk for injury should they faint. If syncope develops, patients should be observed until symptoms resolve.
Children younger than age 12 years are not eligible to receive the Pfizer-BioNTech COVID-19 vaccine at this time. Children and adolescents younger than age 18 years are not eligible to receive the Moderna or Janssen COVID-19 vaccines at this time.
Louisiana Eases Mask Mandate As Infection Rate Plummets
Louisiana Gov. John Bel Edwards lifted his statewide COVID mask mandate except for schools, which must heed recommended quarantine policies before shedding face coverings. Edwards cited a dramatic fall in the state’s infection rate and hospitalizations for his decision. He also noted the potential for children to be eligible for vaccines within weeks, while bemoaning Louisiana’s lagging vaccination rate as 45th in the nation: “We have to do better.” Individual city and parish government leaders, such as New Orleans Mayor Latoya Cantrell, and business owners may still mandate masks at their discretion.
“We have made tremendous progress and I have no doubt that reinstating the mask mandate was a key to this,” Edwards said.
Greg Hilburn, Lafayette Daily Advertiser
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Appendix A: Clinical Trial Evidence Summary For Pfizer
Study C4591001 is the pivotal Phase 1/2/3 trial for the Pfizer-BioNTech COVID-19 vaccine. Evidence on immunogenicity is available participants aged 12 to 15, 16 to 55, and 65 to 85. Evidence on the safety and efficacy of the vaccine is available for adolescents 12-15 years of age and adults 16 years of age and older. Studies did not include participants from long term care facilities. The Phase 2/3 portion of the trial involved approximately 46,000 study participants randomized to receive either the vaccine or placebo. The data presented below are for an interim analysis, therefore the time of follow-up is not consistent but was less than four months after the second dose for all participants.
Evidence from the ongoing Phase 2/3 trial were published in December 2020 and May 2021 respectively, after NACI’s review of the evidence. Evidence from post-marketing surveillance and studies is found in the main body of this statement.
Can People With Underlying Conditions Get Vaccinated Against Covid
Yes, people with underlying conditions are encouraged to get vaccinated as soon as they are able because they tend to be at higher risk of complications from COVID. The available COVID-19 vaccines are safe and effective in people with known medical conditions associated with increased risk of severe disease, such as hypertension, diabetes, asthma, pulmonary, liver, or kidney disease, as well as chronic infections that are stable and controlled.
Although further studies are required for immunocompromised persons, people in this category who are part of a group recommended for vaccination may be vaccinated after receiving impossible that they would pose a risk to immunocompromised persons.
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If My Covid Vaccine Requires Two Doses Does The Second Dose Need To Be From The Same Manufacturer
Yes, WHO recommendations are for the second dose to be from the same manufacturer. There is no need for the two doses to be from the same lot.
In case of severe vaccine shortage, a country may consider administering the Pfizer or Moderna vaccine as the second dose for those who received a first does of the AstraZeneca vaccine. Multiple studies found that this combination is safe and offers adequate protection against SARS-COV-2.
How Is A Vaccine Authorized For Use
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Pfizer Begins Making Pitch To Fda To Clear Kids’ Shots
Dr. William Gruber, a senior vice president of vaccine research and development at Pfizer, began making the pitch to the FDA to clear the company’s vaccine for kids.
He said Covid infections were unpredictable in children and could affect healthy kids almost as easily as those with underlying health conditions. Almost one third of kids hospitalized with Covid were otherwise healthy, he said. He said the need for a safe and effective vaccine was clear.
“Vaccinating children has other large societal benefits,” he said, noting that kids play an important role in transmitting the virus and vaccinating them could help the U.S. reach herd immunity. “Vaccination will help ensure in person learning which is critical for childhood development by limiting community spread and school outbreaks.”
What Are The Side Effects Of The Vaccines
Common side effects that have been reported after getting the vaccines include:
- Pain, redness, or swelling at the injection site
- Feeling tired
- Muscle and joint pain
For the vaccines that require two shots, the side effects might be a little stronger after the second shot compared to what you might have had after the first injection. In general, the side effects tend to go away within a few days.
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My Two Questions Were Simply Whether They Believed The Benefits Of Covid
Dr. Erin Abner, an associate professor of epidemiology at the University of Kentucky’s College of Public Health, said the safety profile of COVID-19 vaccines “is excellent” and, “The question is not ‘get vaccinated and take the risk of side effects or remain unvaccinated and avoid risk’ rather, ‘take the risks of the vaccine, or assume the risks of COVID.'”
Dr. Alison Abraham, a senior associate in the department of epidemiology at Johns Hopkins School of Public Health, said: “The benefits vastly outweigh the harms on both a population and personal level.”
One infectious disease expert in Columbus, Ohio, noted that she didn’t initially think youth should be a high priority for vaccination against the coronavirus, but in the wake of the far more dangerous Delta variant, “I have no hesitation that all age groups should be getting vaccinated as quickly as possible.”
Dr. John Hokanson, a professor of epidemiology at University of Colorado’s Anschutz Medical Campus said he feels so strongly about the protection that vaccines provide that he “would not send to school without vaccinations” if they were still in grade school.
Dr. Kacey Ernst, a professor of epidemiology at the University of Arizona’s College of Public Health, cited an and said: “378 children have died and nearing 18,000 have been hospitalized with COVID-19. I signed up the first day they were eligible.“
Starting Next Year Some Immunocompromised People May Receive A Fourth Covid Vaccine Dose The Cdc Says
Some American adults with weakened immune systems who received a third dose of either the Pfizer-BioNTech or Moderna coronavirus vaccine authorized just for them will become eligible for a fourth shot as a booster next year, according to from the Centers for Disease Control and Prevention.
In such situations, people who are moderately and severely immunocompromised may receive a total of four vaccine doses, with the fourth coming at least six months after the third, the C.D.C.s guidelines said.
In August, federal regulators cleared a third dose of the Pfizer-BioNTech and Moderna vaccines for some immunocompromised recipients of those vaccines, instructing them to get it at least 28 days after their second shot. Federal agencies said that studies have shown that those people may not be adequately protected by just two shots.
The earliest that immunocompromised people who received that third mRNA vaccine shot can get a fourth shot as a booster would be February. The agency said that people could select that booster from any of the three coronavirus vaccines available in the United States.
The C.D.C. also recommends that moderately and severely immunocompromised adults who received Johnson & Johnsons one-dose vaccine get another dose of any one of the three vaccine brands, at least two months after their initial shot.
The new recommendations also specified that a fourth dose of Modernas vaccine should be half the size of a normal dose.
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