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FDA approves BA. 5 vaccine

U.S. Food and Drug Administration, amended the emergency use authorizations (EUAs),

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use

of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine

to authorize bivalent formulations

BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.

Omicron booster shots, with lots of questions

https://www.science.org/content/article/omicron-booster-shots-are-coming-lots-questions

United Kingdom has authorized Moderna Omicron subvariant BA.1

Moderna and Pfizer-BioNTech, have submitted data about their BA.4/BA.5 vaccines

Biden administration

Has already placed an order for 170 million doses

What do the new boosters contain?

Messenger RNA (mRNA) coding for the spike protein of SARS-CoV-2

Bivalent, Wuhan strain and BA.1 or BA.4 and BA.5 (which have identical spikes)

What sort of data have the companies collected?

Human data, only available BA.1 booster

BA.1 trails did not look for protection against severe disease, (People trials are very expensive)

For the BA.4/BA.5 boosters, the companies have submitted animal data.

(not released publicly)

Pfizer presented preliminary findings in eight mice given BA.4/BA.5 vaccines as their third dose, (for EMA)

Showed an increased antibody response to all Omicron variants tested: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5.

Clinical trials for the BA.4/BA.5 vaccines will begin next month

Why still target the ancestral strain?

Probably for new variants, more polyclonal response

Still has some neutralising power against the new variants

If the benefits are limited, do we really need the new boosters?

Some scientists don’t think we do.

Paul Offit, vaccine researcher, Children’s Hospital of Philadelphia

COVID-19 vaccines still prevent the most severe outcomes

If the goal is to stop infections, even updated vaccines will have little impact

(Incubation period is too short)

(Measles or rubella, 2-week incubation period, so can stop spread)

even if 100% of the population were vaccinated,

and the virus hadn’t evolved at all,

vaccines would do very little to stop transmission

https://support.google.com/youtube/answer/11161123

Efficacy of vaccines: content claiming that vaccines do not reduce transmission or contraction of disease

https://support.google.com/youtube/answer/9891785

Claims that any medication or vaccination is a guaranteed prevention method for COVID-19

The Biopharmaceutical Industry Provides 75% Of The FDA’s Drug Review Budget. Is This A Problem?

https://www.forbes.com/sites/johnlamattina/2018/06/28/the-biopharmaceutical-industry-provides-75-of-the-fdas-drug-review-budget-is-this-a-problem/?sh=7bf0d65049ec

Caroline Chen

the agency is beholden to the biopharmaceutical industry

Given this level of support, one might assume that the FDA would bend over backwards to meet the needs of its financial backers.

Caroline Chen ProPublica

https://www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-market

Dr. Thomas Marciniak

(former FDA medical team leader)

You don’t survive as a senior official at the FDA unless you’re pro-industry

The FDA has to pay attention to what Congress tells them to do, and the industry will lobby to get somebody else in there if they don’t like you

Pfizer

https://www.theguardian.com/business/2022/may/03/pfizer-covid-sales-pricing-vaccine-paxlovid-pill

has made nearly $26bn (£21bn) in revenues in the first three months of the year

Covid-19 vaccines and treatments

Expects record sales of $98bn to $102bn this year,

half of which will come from Covid products, Comirnaty and Paxlovid

prompting fresh accusations of pandemic profiteering.

AstraZeneca, Chief executive officer, Pascal Soriot

https://www.independent.co.uk/news/uk/astrazeneca-people-medicines-and-healthcare-products-regulatory-agency-office-for-national-statistics-uk-government-b2154286.html

(27th August)

Most of the vaccinated population has a foundation immunity against severe disease

People who are otherwise healthy – especially if they are young, have been vaccinated, have had a boost already – boosting them again,

I’m just not sure it’s really a good use of resources.

Foundation immunity lasts, a long time, we don’t know if it’s one year, two years, three years.

I think more than one year for sure

On boosting people every year

I’m not sure it’s a really good use of money,

because most of the people now who catch it will just have symptoms if they get Covid, and that’s it

Written by Dr. John Campbell

Hello Everyone,My name is John Campbell and I am a retired Nurse Teacher and A and E nurse based in England. I also do some teaching in Asia and Africa when time permits. These videos are to help students to learn the background to all forms of health care. My PhD focused on the development of open learning resources for nurses nationally and internationally.

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  1. Covid strains should be monitored and vaccine should be designed and limited to herding the virus into less probability to cause serious illness. As Covid will vacine escape and natural immunity should be the primary goal. Maybe that it's T cell vaccines are preferred to target all strains of Covid to create even a limited immune response. And allowing the more dominant which usually is the less lethal strain to become the natural immunity strain. I would be concerned if we decided to create a vacine to target the most dominant rather than the most lethal. I am not a medical scientist, but this seems the most logical approach?

  2. One of the situations that really began to open my eyes to the questioning of vaccines was the media's incoherent and endless pushing of the flu vaccine. Now you would think that most of the public could have figured out that was all a scam. There is no way that vaccines can be created and distributed throughout the world quick enough for them to be effective. By the time the vaccines get out to the public the virus is already mutated and long gone. This leads to health regions having to make guesses years in advance as to what they think the not yet existent viruses will be. Now a regular human would laugh at such a situation. A world that puts far to much trust in doctors and science however…..has a terrible time processing simple information like this that most 3 year old kids can comprehend. Ahhhhhhh buts it's based on models and science and technology. Really? You mean the same types of models that covid numbers were based on? You see…..covid is a highly mutational virus. Perhaps even more so than the flu. There is no way that vaccines can be made and distributed throughout the entire world quick enough to have any significant effect. We are seeing this now with BA4 and BA5. BA4 is all but obsolete and BA5 is on its way out. There is no reason in the world at this point to get vaccinated and yet…..that will not stop people from doing it. Why though? Why does reason not win over the masses? Do u think it might be because they put to much faith in doctors and science and technology? They trust doctors so much…..they put doctors on incredibly high pedestals. Just look at all the admiration John gets from his fans. They trust him completely. It clouds their ability to reason. These vaccines are incredibly dangerous and terribly ineffective. Do you think that is an over statement? Well…..there is no way the FDA would have ever approved these vaccines given the numbers of adverse effects in a regular situation. The heads of the FDA all resigned just days before these vaccines were given approval. Hmmmmmm. I wonder why? We can't be judgemental though or jump to conclusions. We need more DATA on the subject before we can make any solid claims.

  3. The “human tests” where on 40.000 people. Not on alderly and not under 40yrs tested. Also there was NO placebo group, nonsense test!! This last “booster” from the “booster” is “tested” on 8 mice!!l hahahahahahahahaha

  4. 8 mice.. It's only incredible if you factor out corruption. They want to drip feed the spike protein, and make money selling every booster. Vs triggering and antibodie immune response, which would provide much longer, more natural. protection.

  5. Did you just say "induce an antigen"?

    Autoantigens

    Self-antigens are already present within the body and shouldn't trigger an immune response in healthy individuals because the body should know they’re not harmful. However, sometimes the body erroneously acts against them—leading to autoimmune inflammation.

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