A press release has been put out by Pfizer-BioNTech regarding clinical trial results undertaken on schoolchildren:-
PFIZER-BIONTECH ANNOUNCE POSITIVE TOPLIFE RESULTS OF PIVOTAL COVID-19 VACCINE STUDY IN ADOLESCENTS
Wednesday, March 31, 2021 – 06:45am
“We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorisation in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year”.
“Across the globe we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant. It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones”, said Ugur Sahin, CEO and Co-founder of BioNTech.
About the Phase 3 Data from Adolescents 12-15 Years of Age
The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States.
In the trial, 18 cases of COVID-19 were observed in the placebo group (n=1,129) versus none in the vaccinated group (n=1,131). Vaccination with BNT162b2 elicited SARAS-CoV-2-neutralising antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compares well (was non-inferior) to GMTs elicited by participants age 16 to 25 years old (705.1 GMTs) in an earlier analysis. Further BNT162b2 administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age.
The companies plan to submit these data to the FDA and EMA for a requested amendment to the Emergency Use Authorisation of BNT162b2 and the EU Conditional Marketing Authorisation for COMIRNATY to expand use in adolescents 12-15 years of age as quickly as possible. All participants in the trial will continue to be monitored for long-term protection and safety for an additional 2 years after their second dose.
Pfizer and BioNTech plan to submit the data for scientific peer review for potential publication.
Update on the Phase 1/2/3 Study in Children 6 months to 11 years old
Last week Pfizer and BioNTech dosed the first healthy children in a global Phase 1/2/3 study to further evaluate the safety, tolerability and immunogenicity of the vaccine in children 6 months to 11 years of age. This will be in 3 age groups: 5-11 years, 2-5 years and 6 months to 2 years
IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORISATION PRESCRIBING INFORMATION:-
- Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine
- 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
- Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/)
- Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine
- The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients
- In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
- Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
- Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
- Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
- There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series
- Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
- Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization
- Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine-us.com
Pfizer Disclosure Notice
The information contained in this release is as of March 31, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information on future events or developments.
Following the massive politicisation of Covid-19 that we have endured over the past year you would think nothing could shock you any more, and then along comes the vaccination of children with an experimental “vaccine/gene therapy” still in Phase III of clinical trials.
Why on earth would any parent put their healthy child forward for such an experiment?.
We know that the “Covid-19 virus infection fatality rate for children is negligible. Most children have mild or no symptoms at all. Babies/children are equipped with millions of newly-generated immune warriors called T cells (natural immunity has been completely removed from the Covid-19 debate).
- There is no medium/long term safety data on the “vaccine/gene therapy”.
- It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.
Informed Consent/Medical Ethics/International Law
Vaccine Mandates Violate the Right to Informed Consent (if vaccination is a requirement of attending School/University) this will be in breach.
The State and Big Pharma are advocating for child vaccinations before the end of a clinical trial – SURELY THIS IS IN BREACH OF THE NUREMBERG CODE – isn’t it?
I fell into politics quite by accident in 2014 and all because my local County Council brought in a policy switching off street lighting overnight my elderly neighbours felt vulnerable – this spurred me into action and the Right to Light Campaign was born.
I started the Right to Light Petition which garnered over 11,000 signatures enough to trigger a debate at Kent County Council. I delivered a speech in front of 88 Councillors and journalists but they refused to listen to the people and kept the lights off.
I worked closely with a local journalist who followed the campaign from start to finish, publishing articles on an almost weekly basis.
Word spread about the campaign and the Council’s refusal to listen – my phone became a hotline, I was invited onto BBC Breakfast and live radio something I would never have contemplated happening in a million years. Following a fierce 2 year battle and against all the odds streetlighting was restored throughout Kent.
Spurred on by success and having witnessed how badly represented people were at local level I joined UKIP standing as a candidate in Borough and County elections narrowly missing out on a seat by 22 votes on one occasion.
The run-up to the EU Referendum was an exciting time I joined the Grassroots Out Campaign and ran weekly street stalls delivering thousands of leaflets and meeting hundreds of people including Nigel Farage and Gerard Batten. I loved the buzz and the fun was infectious. I have been hooked ever since.
I became a prolific poster on Facebook building up relationships in many groups, I was approached by the owner of a Website/FB page called Fortis est Veritas asking if I would like to write articles to post on his platform. I have to date written 22 articles and really enjoy documenting the twists and turns of Brexit a very exciting time – we are writing history and it is essential that is fully documented.
I am very excited to now be given the opportunity to join the UNN family as a Political Analyst – the next chapter in a very exciting 5 years of my life.