FDA approve BA.5 vaccine, no human trials

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