Covid Vaccines May Soon Be Approved For Young Children In The Us Will Australia Do The Same
Moderna and Pfizer vaccine trials for children six months to five years old look promising and experts say the TGA is likely to approve both
Children under five in the US may soon be eligible for Covid vaccination after a recommendation by regulatory experts this week.
On Wednesday, a US Food and Drug Administration expert panel found that the Pfizer and Moderna Covid vaccines were safe for kids aged six months to five years old.
The panel voted unanimously that the benefits of the vaccines outweighed the risks in children aged six months to five years old for Moderna, and up to four years old for Pfizer. The recommendations for emergency use authorisation are still to be officially approved.
With authorisation in the US imminent, is Australia likely to follow suit?
Fda Schedules Meeting In Advance Of Pfizers Authorization Request For Children Ages 5 To 11 Years Old
Last week, Pfizer began submitting vaccine data to the FDA for children ages 5 to 11. The company also said that they soon plan to submit an authorization request for their vaccine for this group. This announcement followed findings in late September that showed that the vaccine was safe and caused a strong immune response in this population.
In anticipation of Pfizers request, the FDA has scheduled a vaccine advisory committee meeting for October 26. During the meeting, the committee plans to review Pfizers vaccine data for this age group, which uses a lower dose than whats currently available.
New Brunswick Prepares For Covid
New Brunswick will be ready to roll out COVID-19 vaccines to children under five as soon as they’re approved and available, according to the chief medical officer of health.
The province is also working on an early flu vaccination campaign in anticipation of “a higher than normal” influenza season this year, said Dr. Jennifer Russell.
In the U.S., immunization of infants and preschoolers against COVID-19 began this week after the Food and Drug Administration authorized emergency use of the Moderna and Pfizer-BioNTech vaccines in children as young as six months old last Friday, and the Centers for Disease Control and Prevention recommended use of the vaccines in this age group the following day.
No COVID-19 vaccine has been approved for children under five in Canada yet. Health Canada is reviewing an application from Moderna.
“We are waiting for Health Canada as well as NACI to come forth with their recommendations,” said Russell.
The province is “watching very closely,” she said, and is “ready to act on those when they come through.”
Russell could not estimate when that might be.
“But we are preparing ahead of time for that inevitability.”
No details yet
Planning for the rollout is underway, said Department of Health spokesperson Michelle Guenard.
The department is working with its primary care partners, including the regional health authorities, community pharmacies and the New Brunswick Medical Society, she said.
Spike in flu cases
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Pfizer Booster Authorized For Older Adults People With High Exposure Risk And Those At Risk For Severe Covid
Yesterday, the FDA a single booster dose of Pfizers COVID-19 vaccine for special populations. This announcement follows their expert panels last week to authorize booster shots for certain groups without approving them for the general public.
The panel debated whether or not boosters are needed right now, considering data shows that the vaccines are still very effective at preventing hospitalization and death from COVID-19. Given the limited data on boosters, the FDA agreed that the known benefits outweigh the risks for higher-risk groups but not for the general public at this time.
Under the , the following groups would be eligible for Pfizer boosters at least 6 months after their initial shots:
Adults at least 65 years old
Adults at high risk for severe COVID-19
Adults with frequent exposure to COVID-19 through their jobs or other settings that puts them at high risk for serious COVID-19 complications
Who is considered to be at high risk for severe COVID-19
What is considered to be frequent COVID-19 exposure
Term Of The Week: Fellowship Of Friends
The Fellowship of Friends is a small religious sect based in northern California. Founded in 1970, the group, which has around 1,500 members worldwide, is best known for its love of fine arts and culture, according to The New York Times. Inside the organizations Northern California compound, called Apollo, the Fellowship staged operas, plays and ballets ran a critically acclaimed winery and collected art from across the world, the article noted.
The Fellowship of Friends is at the center of a big controversy at Google, which has been sued over its alleged favoritism toward members of the group. As many as 12 Fellowship members and close relatives worked for the Google Developer Studio, or GDS, which produces videos showcasing the companys technologies. … Many others staffed company events, working registration desks, taking photographs, playing music, providing massages and serving wine, which had been purchased from a winery owned by a group member, The New York Times reported.
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What About Fourth Booster Doses In Adults Who Is Eligible
Atagi last month released recommendations for a fourth Covid vaccine dose for at-risk populations, including people older than 65, Aboriginal and Torres Strait Islander people aged 50 and above, aged and disability care residents, and individuals who are severely immunocompromised.
These groups are encouraged to get the fourth dose four months after their previous jab.
The Victorian premier, Daniel Andrews, indicated on Thursday that the state was considering fourth doses for healthcare workers. Whilst a month or two ago maybe, a fourth dose for health workers wasnt deemed necessary the advice from the ground is that we need to get this done, he said.
Is It Safe To Give Children A New Vaccine
Millions of people in the U.S. have received COVID-19 vaccines under the most intense safety monitoring in the countrys history, the CDC says. And although the COVID-19 vaccines are new, the mRNA technology used in Pfizers and Modernas vaccines has been studied for about 15 years.
What scientists know is that mRNA molecules occur naturally in humans, and the molecules from the vaccine are destroyed and dont stay in the body. This means they are safe for growing bodies and should not affect puberty, fertility, or brain development, Dr. Murray says.
We have years of experience of giving vaccines to children, and the safety record is exceedingly positive, Dr. Murray says. And with the millions of doses we have given in the 12 and older group thus far, it has proven to be a very effective and safe vaccine.
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What Was Pfizer And Modernas Testing Process For The Vaccine In This Age Group
Several thousand children were given either the vaccine or a placebo and then closely followed for months.
Two-thirds received the vaccine, and the other third received a placebo for comparison. Over a number of months, Pfizer and Moderna tested different dosages to find the best one for this age groups immune system.
Description Of Moderate And Severe Immunocompromising Conditions And Treatment
Moderate and severe immunocompromising conditions and treatments include but are not limited to:
- Active treatment for solid tumor and hematologic malignancies
- Receipt of solid-organ transplant and taking immunosuppressive therapy
- Receipt of chimeric antigen receptor -T-cell therapy or hematopoietic cell transplant
- Moderate or severe primary immunodeficiency
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids , alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor blockers, and other biologic agents that are immunosuppressive or immunomodulatory
Factors to consider in assessing the general level of immune competence in a patient include disease severity, duration, clinical stability, complications, comorbidities, and any potentially immune-suppressing treatment. Age or place of residence alone , independent of a patients medical condition, should not be used to determine the level of immune competence, as the balance of benefits and risks of a third primary dose for people who are not moderately or severely immunocompromised is currently unknown.
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Which Benefits Might Not Be Known When A Covid
When EMA first approves a vaccine, some benefits may still be uncertain. The benefits will only become clearer after the vaccine is in use.
Over time, regulators may get more information about:
- asymptomatic cases after vaccination, i.e thenumber of people who get infected with the virus but do not develop symptoms. This is important because these people can still spread the virus to others
- whether the vaccine can reduce the spread of the virus in the community. Reducing transmission will depend on many factors, including how many people get vaccinated
- the vaccines effectiveness in the real world, i.e. outside the controlled setting of clinical studies.
Primary Series For People Who Are Moderately Or Severely Immunocompromised
mRNA COVID-19 vaccines
A 3-dose primary series is recommended for people ages 5 years and older who are moderately or severely immunocompromised at the time of vaccination . The same mRNA vaccine product should be used for all doses of the primary series .
Pfizer-BioNTech COVID-19 Vaccine : The second dose is administered 3 weeks after the first dose the third dose is administered at least 4 weeks after the second dose.
Moderna COVID-19 Vaccine : The second dose is administered 4 weeks after the first dose the third dose is administered at least 4 weeks after the second dose. The dose is 100 µg for all doses in the primary series.
An mRNA vaccine is preferred, but a single primary Janssen vaccine dose can be used for people ages 18 years and older who are moderately or severely immunocompromised, followed by a second dose using an mRNA COVID-19 vaccine at least 4 weeks later . If Moderna COVID-19 vaccine is used for the second dose, administer a 100 µg dose.
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What Are Efficacy Studies
Efficacy studies are large studies that evaluate the benefit of a medicine. For vaccines, these studies usually involve thousands of volunteers. The main efficacy studies for COVID-19 vaccines involve tens of thousands of participants.
Developers first test first the vaccine’s efficacy in people who have not previously come into contact with the virus that causes COVID-19 disease. These people are more difficult to protect than people who have already come into contact with the virus. They represent the majority of the general population.
The feasibility of determining whether a vaccine can protect people against disease depends on whether the virus is circulating and on whether there are any cases of disease that can be prevented.
Who Else Can Take The Vaccine
Vaccination is recommended for people living with conditions that have been identified as increasing the risk of severe COVID-19, including cardiovascular disease, respiratory disease, diabetes, liver disease, obesity and neurodevelopmental and neurodegenerative conditions.
The vaccine can be offered to people who have had COVID-19 in the past. Available data shows that symptomatic reinfection from the same variant is unlikely for up to 6 months after infection. Those with documented infection may therefore choose to delay vaccination to nearer the end of this period, especially when vaccine supply is limited, to allow others priority for vaccination.
WHO recommends the same use of Novavax vaccine in breastfeeding and non-breastfeeding women. Data are not available on the potential benefits or possible risks of the Novavax vaccine to breastfed children. However, as Novavax vaccine is not a live virus vaccine, it is biologically and clinically unlikely to pose a risk to the breastfeeding child. WHO does not recommend discontinuing breastfeeding because of vaccination.
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How Are Clinical Studies Carried Out In Other Parts Of The World
Since the COVID-19 pandemic affects people worldwide, it is important for companies developing COVID-19 vaccines to generate robust evidence that meets the needs of regulators around the globe. This is why EMA and other medicines regulators have agreed key principles on how to carry out clinical trials for COVID-19 vaccines.
Companies applying for approval of a vaccine in the EU must ensure that clinical studies meet stringent EU requirements no matter where in the world they took place.
For more information, see:
What Studies Are Needed After Approval
Data from long-term clinical studies on safety and efficacy are important for a number of reasons. These data allow the assessment of how protection against COVID-19 evolves over time, such as if the level of antibodies in the blood might go down after some time.
Long-term data are also important to assess whether there is any risk of vaccine-associated enhanced disease . VAED is a condition that would occur when a vaccinated person subsequently infected with a virus develops a more severe disease than they would have had if they were not vaccinated.
This has been seen in animal models given vaccines against SARS or MERS and never with humans given such SARS or MERS vaccines. VAED has not been seen with COVID-19 vaccines in any studies done so far.
For more information, see:
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About The Clinical Considerations
- COVID-19 vaccines currently approved or authorized by FDA are effective in preventing serious outcomes of coronavirus disease 2019 , including severe disease, hospitalization, and death.
- COVID-19 primary series vaccination is recommended for everyone ages 5 years and older in the United States for the prevention of COVID-19.
- A 3-dose primary mRNA COVID-19 vaccine series is recommended for people ages 5 years and older who are moderately or severely immunocompromised, followed by a booster dose in those ages 12 years and older.
- In most situations, Pfizer-BioNTech or Moderna COVID-19 Vaccines are preferred over the Janssen COVID-19 Vaccine for primary and booster vaccination.
- At least 1 booster dose of COVID-19 vaccine is recommended for everyone ages 12 years and older. Recommendations for booster dose vary based on age, COVID-19 vaccine product, and immunocompetence.
- Efforts to increase the number of people in the United States who are up to date with their COVID-19 vaccines remain critical to preventing illness, hospitalizations and deaths from COVID-19.
- These clinical considerations provide additional information to healthcare professionals and public health officials on use of COVID-19 vaccines.
Pfizer Requests Booster Authorization For People As Young As 16 Years Old
Yesterday, Pfizers CEO announced that the company has submitted an authorization request for COVID-19 booster shots in people as young as 16 years old. Booster shots with Pfizers COVID-19 vaccine are currently recommended for all adults age 18 and older, depending on when they finished their initial vaccination series.
Pfizers vaccine is the only one authorized for use in people under 18 years old. That means people as young as 16 years old could be eligible for a booster 6 months after their second shot.
Its been reported that authorization for this age group could happen within a week. After the FDA issues a decision, the CDC will need to weigh in with recommendations, too.
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Consent For People 12
Currently, people ages 12-17 can only get the Pfizer/Comirnaty vaccine.
A legally authorized representative must give permission for vaccination for someone 12-17 years of age, such as by completing a written consent form that the minor can bring to their vaccination appointment. Please contact the vaccination location for more information on written consent, or a copy of the consent form below. People aged 12-17 are eligible to receive the Pfizer/Comirnaty vaccine.
The parent or guardian does not need to go with the minor to their vaccination appointment to give consent. If the parent or guardian is not accompanying the minor, they should download and complete a pre-vaccination screening form, available at mass.gov/CDCScreeningForm. The form is available in several languages.
Approval Signifies Key Achievement For Public Health
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 , 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 , 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.
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Cdc Recommends Pfizer Booster Shots For Certain People But Moderna And Johnson & Johnson Booster Shots Not Yet Recommended
Today, the CDC announced that Pfizer booster shots are recommended for certain populations.
This recommendation follows a meeting from yesterday by a CDC expert panel. This panel discussed and voted on the potential risks and benefits of a booster shot. Today, CDC Director, Dr. Rochelle Walensky, formally announced the agencys endorsement of the Pfizer COVID-19 vaccine booster shot.
A few groups of people now qualify for a Pfizer booster shot at least 6 months after their second dose. This includes:
People 65 or older
People between 50 and 64 who have certain medical conditions, such as asthma, kidney disease, or diabetes
People living in long-term care facilities
Other people may qualify for a booster shot depending on the situation. If a healthcare provider decides that the benefits of a booster shot outweigh its risks, they can give a booster shot to certain people at least 6 months after their second dose. This group includes:
People between 18 and 49 who have certain medical conditions, such as asthma, kidney disease, or diabetes
People between 18 and 64 who work in a setting where theyre frequently exposed to COVID-19
This information only applies to the Pfizer vaccine not the Moderna or Johnson & Johnson vaccines. A Pfizer booster shot can help improve protection against COVID-19 for certain people. If you have questions, please reach out to your healthcare provider for additional guidance.