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Hacked EMA emails and mRNA vaccine stability

This week a piece in the British Medical Journal provides some insight into how the medical regulatory bodies scrutinised the novel RNA vaccines that were the science marvels of 2020.

Investigative journalist Serena Tinari was one of the people who received anonymously a large, though selective, bundle of hacked emails and documents dating back to November copied from the servers of the European Medicines Agency.

They make mention of concerns the Agency had over the levels of effective RNA contained in some batches of the industrially produced Pfizer Biontech Covid vaccine compared to the laboratory produced doses.

The EMA did subsequently licence the vaccine - the problem having presumably been solved. However, as Serena describes, she was then surprised that the companies and agencies she and the BMJ approached would not tell her what the threshold was for adjudging acceptable levels, given as is well known, the fragility of mRNA and the need to store it carefully.

They said it was commercially sensitive. But as RNA researcher Prof Anna Blakney tells Science in Action, there are fascinating reasons why that might simply not be known, and also why precise accuracy likely doesn’t matter too much compared to the better-known clinical efficacy these vaccines continue to demonstrate.

2nd item in this episode - programme available for 28 days from post date
https://www.bbc.co.uk/programmes/w3cszky4

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the BMJ Article is here -- March 10 2021 https://www.bmj.com/content/372/bmj.n627

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also released today  is the latest on the Oxford AZ vaccine from the Norwegian Medicines Agency on the 4 cases of blood clots so far reported there.

they recommend those who feel increasingly unwell with several large blue patches (skin haemorrhages) more than three days after vaccination, to consult the out-of-hours medical service or their doctor as soon as possible.


Similar incidents have been reported in other European countries, and the European Medicines Agency (EMA) is considering whether there may be an association with the coronavirus vaccines. So far, no conclusion has been reached.


Common to these patients is that they have had a reduced number of blood platelets. Blood clots and subsequent brain haemorrhages are a rare condition.

https://www.fhi.no/en/news/2021/norwegian-medicines-agency-notified-of-blood-clots-and-bleeding-in-younger-/

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Comment on above

remember we are all different, age , gender, medical condition and history and many of us even physiologically/biochemically and for example , the birth control pill also causes blood clots and a million more side affects yet it is often used for many menstrual cycle complaints.

also

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also

"
At the time of this report, nearly 125,000 people across the UK have died within 28 days of a positive test for coronavirus (COVID-19). Rates of COVID-19 infection and hospitalisation remain high.Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020.Two COVID-19 vaccines, Pfizer/BioNTech and Oxford University/AstraZeneca vaccines, are currently being used in the UK. Both have been authorised for supply by the Medicines and Healthcare products Regulatory Agency (MHRA) following a thorough review of safety, quality and efficacy information from clinical trials. In clinical trials, both vaccines showed very high levels of protection against symptomatic infections with COVID-19. We expect data to be available soon on the impact of the vaccination campaign in reducing infections and illness in the UK.All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.

As of 28 February 2021, for the UK, 33,207 Yellow Cards have been reported for the Pfizer/BioNTech, 54,180 have been reported for the Oxford University/AstraZeneca vaccine, and 251 have been reported where the brand of the vaccine was not specified.For both vaccines the overall reporting rate is around 3 to 6 Yellow Cards per 1,000 doses administered.

In the week since the previous summary for 21 February 2021 we have received a further 3,492 Yellow Cards for the Pfizer/BioNTech vaccine, 11,263 for the Oxford University/AstraZeneca vaccine and 74 where the brand was not specified. A higher number of doses of the Oxford University/AstraZeneca vaccine were administered in the last week than the Pfizer/BioNTech vaccine.

It is important to note that Yellow Card data cannot be used to derive side effect rates or compare the safety profile of COVID-19 vaccinations as many factors can influence ADR reporting.

For both vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.These types of reactions reflect the normal immune response triggered by the body to the vaccines. They are typically seen with most types of vaccine and tend to resolve within a day or two. The nature of reported suspected side effects is broadly similar across age groups, although, as was seen in clinical trials and as is usually seen with other vaccines, they may be reported more frequently in younger adults.

Severe allergy
On 9 December 2020, the MHRA issued preliminary guidance on severe allergic reactions after the Pfizer/BioNTech vaccine due to early reports of anaphylaxis. Following further detailed review, this advice was amended on 30 December to the current advice. This advice is that people with a previous history of severe allergic reactions to any ingredients of the vaccine should not receive it. People who receive the vaccine should be monitored for at least 15 minutes afterwards.

Widespread use of the vaccine now suggests that severe allergic reactions to the Pfizer/BioNTech vaccine are very rare. Anaphylaxis can also be a very rare side effect associated with most other vaccines.

Following very substantial exposure across the UK population, no other new safety concerns have been identified from reports received so far.

Conclusion

The increases in number of ADR reports reflects the increase in vaccine deployment as new vaccination centres have opened across the UK The number and nature of suspected adverse reactions reported so far are not unusual in comparison to other types of routinely used vaccines    The overall safety experience with both vaccines is so far as expected from the clinical trials Based on current experience, the expected benefits of both COVID-19 vaccines in preventing COVID-19 and its serious complications far outweigh any known side effects   

As with all vaccines and medicines, the safety of COVID-19 vaccines is being continuously monitored

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

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a new safety review of 10 million patients who received the vaccine uncovered

"no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any defined age group, gender, batch or in any particular country.

"In fact, the observed number of these types of events are significantly lower in those vaccinated than what would be expected among the general population,"



https://www.cbc.ca/news/world/coronavirus-covid19-canada-world-march11-2021-1.5945218