Dr Bauer of the Francis Crick Institute explains that the Pfizer vaccine produces 5-6 times fewer neutralising antibodies that play a key role in protecting us from the Indian variant. He suggests that booster Pfizer jabs will be essential.
BioNTech
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Levels of antibodies in the blood of vaccinated people that are able to recognise and fight the new SARS-CoV-2 Delta variant first discovered in India (B.1.617.2) are on average lower than those against previously circulating variants in the UK, according to new laboratory data from the Francis Crick Institute and the National Institute for Health Research (NIHR) UCLH Biomedical Research Centre, published today (Thursday) as a Research letter in The Lancet.
The results also show that levels of these antibodies are lower with increasing age and that levels decline over time, providing additional evidence in support of plans to deliver a vaccination boost to vulnerable people in the Autumn.
In the case of single-dose recipients, our data show that NAbTs are significantly lower against B.1.617.2 and B.1.351 VOCs relative to B.1.1.7, implying that although a single dose might still afford considerably more protection than no vaccination, single-dose recipients are likely to be less protected against these SARS-CoV-2 variants. These data therefore suggest that the benefits of delaying the second dose, in terms of wider population coverage and increased individual NAbTs after the second dose,7 must now be weighed against decreased efficacy in the short-term, in the context of the spread of B.1.617.2. Worldwide, our data highlight the ongoing need to increase vaccine supply to allow all countries to extend second-dose protection as quickly as possible.
In the longer term, we note that both increased age and time since the second dose of BNT162b2 significantly correlate with decreased NAb activity against B.1.617.2 and B.1.351—both of which are also characteristic of the population in the UK at highest risk of severe COVID-19 (ie, older and vaccinated earlier), independent of other existing factors such as compromised immune status or comorbidity, or geographic-specific responses to vaccination.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01290-3/fulltext
CDC looking into reports that a small number of teens and young adults vaccinated against the coronavirus that may have experienced heart problems
Condition, known as myocarditis, results in an inflammation of the heart muscle which can occur following certain infections
Problems have been occurring four days after the second dose has been given
Dozens of cases have been reported to the agency in recent week
It is not yet clear which vaccine might be responsible, Moderna or Pfizer
The agency’s vaccine safety group was sparse in details, saying only that there were ‘relatively few’ cases and levels were similar to normal
Group also said that the conditions may be entirely unrelated to vaccination
Nine executives from Moderna, BioNTech, ROVI and CanSino Biologics have all become billionaires throughout the pandemic
Together they are now worth $19.3 billion – a combined net wealth greater than what it would cost to vaccinate the world’s poorest nations
The list was compiled by the People’s Vaccine Alliance, a campaign group that includes Oxfam, UNAIDS, Global Justice Now and Amnesty International
Moderna CEO Stéphane Bancel is now worth a whopping $4.3 billion after his company was granted emergency use authorization in the US in December
CEO and co-founder of BioNTech Ugur Sahin is close behind with a wealth of $4 billion, following its collaboration on a vaccine with Pfizer
Senior executives from CanSino Biologics have also become billionaires after it developed a one-shot vaccine that was approved for use in China this February
It comes as world leaders will discuss at the G20 Global Health Summit whether to waive patent protections for COVID-19 vaccines
Supporters say it will allow more manufacturers to produce life-saving vaccines and increase their supply to poorer countries
Hard to justify right now for most children in most countries
Following widespread vaccination against SARS-CoV-2 of older adults and other highly vulnerable groups, some high income countries are now considering vaccinating children; just days ago, the US Food and Drug Administration authorized the use of the Pfizer/BioNTech vaccine in children 12-15 years of age. Young people have been largely spared from severe covid-19 so far, and the value of childhood vaccination against respiratory viruses in general remains an open question for three reasons: the limited benefits of protection in age groups that experience only mild disease; the limited effects on transmission because of the range of antigenic types and waning vaccine induced immunity; and the possibility of unintended consequences related to differences in vaccine induced and infection induced immunity. We discuss each in turn.
The vaccine brought in $3.5 billion in revenue in the first three months of this year, nearly a quarter of its total revenue, Pfizer reported. The vaccine was, far and away, Pfizer’s biggest source of revenue.
On Tuesday, the company announced just how much money the shot is generating.
The vaccine brought in $3.5 billion in revenue in the first three months of this year, nearly a quarter of its total revenue, Pfizer reported. The vaccine was, far and away, Pfizer’s biggest source of revenue.
The company did not disclose the profits it derived from the vaccine, but it reiterated its previous prediction that its profit margins on the vaccine would be in the high 20 percent range. That would translate into roughly $900 million in pretax vaccine profits in the first quarter.
https://www.nytimes.com/2021/05/04/business/pfizer-covid-vaccine-profits.html
Danish authorities have opted for a more cautious path, even though Reuters reported that excluding J&J’s shot could significantly delay the country’s vaccination efforts.
Danish drug officials last month abandoned the use of AstraZeneca’s Covid-19 vaccine, also citing the risk of blood clots. In March, Denmark became the first country in the world to temporarily suspend the AstraZeneca shot, but unlike its European neighbors, the country made that suspension permanent.
https://www.rt.com/news/522790-denmark-cancels-johnson-vaccine/
Schools back mass vaccinations for children, with headteachers saying that “peer pressure” will boost take up.
Education leaders would be willing to help facilitate a vaccine roll-out at schools around the country, according to Geoff Barton, general secretary of the Association of School and College Leaders (ASCL), the largest union for secondary school heads.
…“I think there will be a sense of schools wanting to step up and play their part and explain to children why having the vaccine is important during assemblies and in tutor time.”
…He explained that vaccinating children at school could result in higher take-up because pupils would not want to feel socially isolated by refusing to have the jab.
…“The peer pressure of seeing that your friends are lining up to do it is likely to make the overall numbers taking up the vaccine higher,” he said. Some scientists have argued that if Covid rates rose significantly it would be a priority to vaccinate children to prevent any more disruption or closures of schools during the next academic year.
Many of the vaccines developed to protect against COVID-19 are forms of messenger RNA (mRNA) vaccines.
The Moderna and Pfizer/BioNTech vaccines are forms of mRNA vaccine.
Unlike the Pfizer/BioNTech and Moderna coronavirus vaccines, the Oxford/AstraZeneca vaccine is not an mRNA vaccine.
Instead, the AstraZeneca vaccine is a viral vector vaccine made from a weakened form of a common cold virus from chimpanzees.
Robin Hauser, a pediatrician in Tampa, Florida, got COVID in February. What separates her from the vast majority of the tens of millions of other Americans who have come down with the virus is this: She got sick seven weeks after her second dose of the Pfizer-BioNTech vaccine.
https://www.pbs.org/newshour/health/the-shock-and-reality-of-catching-covid-after-being-vaccinated
All UK spontaneous reports received between 9/12/20 and 05/04/21 for COVID-19 vaccine mRNA Pfizer/BioNTech vaccine analysis print
Shortly after the World Health Organization declared Covid-19 a global pandemic on March 11, 2020, markets collapsed and economies around the world plunged into recession. At the same time, hundreds of billionaires fell from the ranks of Forbes’ World’s Billionaires list, capturing a snapshot of the pandemic’s impact on the fortunes of the world’s wealthiest people.
Two embryonic cell lines have been used to develop COVID-19 vaccines: human embryonic kidney cells called HEK 293 and human embryonic retinal cells called PER.C6. The PER.C6 cell line is from an elective abortion in the Netherlands in 1985, and the HEK 293 cell line comes from an undisclosed source (either spontaneous miscarriage or elective abortion) in the Netherlands in about 1972.
Johnson & Johnson used PER.C6 cells in their COVID-19 vaccine development, and the Oxford/AstraZeneca vaccine used HEK 293 cells. CanSino Biologics and Gamaleya Research Institute’s Sputnik V vaccines have also used HEK 293 cells.
Moderna and Pfizer/BioNTech used HEK 293 cells in their proof-of-concept tests to see effectively take up the genetic instructions contained in these vaccines and produce the required spike protein. But human embryonic cell lines were not used to make either company’s final vaccine.
HEK 293 and PER.C6 cell lines have been genetically altered to include the part of the adenovirus instructions that trigger replication of adenoviruses. This allows the production of a large amount of the final vaccination product and allows the removal of the adenoviral replication instructions in the vaccine.
The BMJ has reviewed the documents, which show that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production.
EMA scientists tasked with ensuring manufacturing quality—the chemistry, manufacturing, and control aspects of Pfizer’s submission to the EMA—worried about “truncated and modified mRNA species present in the finished product.” Among the many files leaked to The BMJ, an email dated 23 November by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications. EMA responded by filing two “major objections” with Pfizer, along with a host of other questions it wanted addressed.
https://archive.today/2022.12.06-175136/https://www.bmj.com/content/372/bmj.n627
Leaked documents show that some early commercial batches of Pfizer-BioNTech’s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari
A request for Emergency Use Authorization in the US was submitted the same month; and the vaccine was then authorized in the US on December 11 (shortly after UK authorization on December 2).
The trial is not over, however: as all subjects are monitored for a further two year period. And the next step is to test the vaccine in groups that cannot currently receive the vaccine due to a lack of data – such as pregnant women and children (Pfizer has already started a trial in pregnant women and one in children is set to follow later this year).
Reference is made to the Request for Comments and Advice submitted 04 February 2021 regarding Pfizer/BioNTech’s proposal for the clinical and post-authorization safety data package for the Biologics License Application (BLA) for our investigational COVID-19 Vaccine (BNT162b2). Further reference is made to the Agency’s 09 March 2021 response to this request, and specifically, the following request from the Agency.
The download link is available from Public Health and Medical Professionals for Transparency.
Important points from this report include:
- A seven-year-old experienced a stroke.
- One child and one infant suffered facial paralysis.
- One infant had a kidney adverse event, either kidney injury or failure.
- Of the 34 cases, 24 (71%) were classified as serious.
- Predominantly female patients were affected — at least 25 of 34 (73.5%) patients.
- Table 6 reports 34 cases of use in pediatric individuals. However, 28 additional cases were excluded because details such as height and weight were “not consistent with pediatric subjects.”
- Ages ranged from two months to nine years, with median 4.0 years, which means half the children were under four years of age.
- 132 adverse events were reported in the 34 children – i.e., an average of 3.88 AEs per child.
Summary from Daily Clout journalists:
Abstract
Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public. The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that affects the interpretation of vaccine efficacy. The present article uses clinical epidemiologic tools to critically appraise reports of efficacy in Pfzier/BioNTech and Moderna COVID-19 mRNA vaccine clinical trials. Based on data reported by the manufacturer for Pfzier/BioNTech vaccine BNT162b2, this critical appraisal shows: relative risk reduction, 95.1%; 95% CI, 90.0% to 97.6%; p = 0.016; absolute risk reduction, 0.7%; 95% CI, 0.59% to 0.83%; p < 0.000. For the Moderna vaccine mRNA-1273, the appraisal shows: relative risk reduction, 94.1%; 95% CI, 89.1% to 96.8%; p = 0.004; absolute risk reduction, 1.1%; 95% CI, 0.97% to 1.32%; p < 0.000. Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction measures. Reporting absolute risk reduction measures is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy.
Conclusions
A critical appraisal of phase III clinical trial data for the Pfizer/BioNTech vaccine BNT162b2 and Moderna vaccine mRNA-1273 shows that absolute risk reduction measures are very much lower than the reported relative risk reduction measures. Yet, the manufacturers failed to report absolute risk reduction measures in publicly released documents. As well, the U.S FDA Advisory Committee (VRBPAC) did not follow FDA published guidelines for communicating risks and benefits to the public, and the committee failed to report absolute risk reduction measures in authorizing the BNT162b2 and mRNA-1273 vaccines for emergency use. Such examples of outcome reporting bias mislead and distort the public’s interpretation of COVID-19 mRNA vaccine efficacy and violate the ethical and legal obligations of informed consent.
Liver samples were collected over time and the concentrations of ALC-0315 and ALC-0159 in each sample were measured. The conclusion As a result, ALC-0315 and ALC-0159 were shown to be rapidly distributed from the blood to the liver. Also, About 1% and about 50% of the doses of ALC-0315 and ALC-0159 are excreted in feces as unchanged drug, respectively.
https://www.pmda.go.jp/drugs/2021/P20210212001/672212000_30300AMX00231_I100_1.pdf