FDA approves BA. 5 vaccine

Sherrod Brown faces criticism for his voting record, particularly regarding benefits for illegal immigrants, including Social Security and healthcare funding. Opponents argue that Brown has prioritized these benefits over the needs of Ohio veterans, claiming he has broken promises to those who served in the military. The discussion highlights a growing concern among constituents about the allocation of taxpayer dollars.

In a separate topic, the FDA has approved a new bivalent COVID-19 vaccine targeting the BA.4 and BA.5 variants, despite concerns over the limited data supporting its efficacy. Critics note that the approval is based on studies involving only eight mice, raising questions about the robustness of the evidence. Human trials for the BA.4 and BA.5 vaccine are set to begin next month, yet the FDA has moved forward with emergency use authorization, prompting calls for a more thorough review of the data before widespread distribution.

Experts express skepticism about the effectiveness of the new boosters, particularly in preventing transmission due to the short incubation period of the Omicron variant. The ongoing debate reflects broader concerns about vaccine efficacy and the pharmaceutical industry's influence on regulatory processes, as well as the financial motivations behind vaccine development.

U.S. Food and Drug Administration, amended the emergency use authorizations (EUAs),Uploaded 07-09-22https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-useof the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccineto authorize bivalent formulationsBA.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-questionsUnited Kingdom has authorized Moderna Omicron subvariant BA.1Moderna and Pfizer-BioNTech, have submitted data about their BA.4/BA.5 vaccines Biden administrationHas already placed an order for 170 million dosesWhat do the new boosters contain?Messenger RNA (mRNA) coding for the spike protein of SARS-CoV-2Bivalent, 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 boosterBA.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 monthWhy still target the ancestral strain?Probably for new variants, more polyclonal responseStill has some neutralising power against the new variantsIf 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 PhiladelphiaCOVID-19 vaccines still prevent the most severe outcomesIf 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 transmissionhttps://support.google.com/youtube/answer/11161123Efficacy of vaccines: content claiming that vaccines do not reduce transmission or contraction of disease https://support.google.com/youtube/answer/9891785Claims that any medication or vaccination is a guaranteed prevention method for COVID-19The 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=7bf0d65049ecCaroline Chenthe agency is beholden to the biopharmaceutical industryGiven this level of support, one might assume that the FDA would bend over backwards to meet the needs of its financial backers.Caroline Chen ProPublicahttps://www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-marketDr. Thomas Marciniak(former FDA medical team leader)You don’t survive as a senior official at the FDA unless you’re pro-industryThe 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 youPfizerhttps://www.theguardian.com/business/2022/may/03/pfizer-covid-sales-pricing-vaccine-paxlovid-pillhas made nearly $26bn (£21bn) in revenues in the first three months of the yearCovid-19 vaccines and treatmentsExpects record sales of $98bn to $102bn this year, half of which will come from Covid products, Comirnaty and Paxlovidprompting fresh accusations of pandemic profiteering.AstraZeneca, Chief executive officer, Pascal Soriothttps://www.independent.co.uk/news/uk/astrazen Learn more about your ad choices. Visit megaphone.fm/adchoices