Barts-MS rose-tinted-odometer: ★★★★★
The horse’s mouth = the MHRA (Medicines and Healthcare products Regulatory Agency)
I have received several vexatious emails accusing me of subjecting my patients, and people with MS (pwMS) in general, to an experiment by recommending and promoting the COVID-19 vaccines. I want to remind the readers that we need to listen to experts. I was challenged that may be the experts are wrong. So if the experts are wrong which regulators should I challenge first; the FDA, EMA, MHRA, Russian, Swiss, Japanese, Canadian, etc.? Have they all got it wrong?
Yes, occasionally a single regulatory authority may get things wrong, but they have checks and balances in place to correct their errors. As so many regulatory authorities have approved these vaccines is very telling. In addition, for most of the regulatory authorities above their approvals have been unanimous, i.e. all the experts and representatives on their panels have agreed that the safety and efficacy of the COVID-19 vaccine warrant their emergency marketing authorisations.
Some of these vexatious commentators state that these vaccines were developed too quickly. Yes, they were developed quickly, but not too quickly. The platforms used for these vaccines were already in place and all that had to be done was to slot in the SARS-CoV-2 spike protein immunogen, tweak the production methods and the vaccines were ready for mass production. For the Oxford-AstraZeneca vaccine, all they had to do was swap out the sequence for the coronavirus that causes MERS for SARS-CoV-2. The latter process happened within a week or two.
Instead of doing trials in series a lot of the clinical development was done in parallel, i.e. phase 1b/2 immunological studies were done as part of phase 2 trials and phase 3 studies were added-on in an adaptive way to phase 2 trials. The reason for this turbocharging or the development pathway was that governments had derisked the development of the vaccines and given money to the companies to develop and test vaccines. In parallel governments also provided capital to build production facilities etc.
So in summary the vaccine development programme was sped up by capital and contracts by governments for a defined number of orders. In normal times this does not happen, hence the many years it ‘normally takes’ to develop a vaccine. In my opinion, no short-cuts were made in terms of testing these vaccines for safety and efficacy. In fact, one could argue that the COVID-19 spike protein vaccines, as a body, represent the largest safety trial programme in vaccine history.
Now that the vaccines have been used on millions of people if there were any rare sinister adverse events we would have expected the regulatory agencies to have reported them. And yes they have. The only one that sticks out from the Israeli and UK experiences is Bell’s palsy, as a rare adverse event, with the Pfizer-Biontech and probably the AstraZeneca-Oxford vaccine as well.
I would like to remind these vexatious commentators that there is no conspiracy theory behind the COVID-19 vaccines and vaccination programmes. What public health officials are doing is simply trying to save lives, protect healthcare services and to stop the pandemic.
Dare I suggest that the ‘post-truth era’ is coming to an end and that politicians, patients and the public will start to value experts again? As a society, we spend an extraordinary amount of time and money to educate and train experts to manage and run institutions such as the FDA, EMA, MHRA, CDC, WHO, etc. These experts need to be trusted and respected; all they are doing is what they have been asked by us to do.
We all have a responsibility to act responsibly and to not dismiss COVID-19 vaccines as being ineffective, unsafe and designed to anything else other than what is in their labels. In general, these vaccines are very effective, safe and reduce your chances of getting severe COVID-19 and dying from COVID-19 by well over 95%. Why wouldn’t you want the vaccine?
Ingrid Torjesen. Covid-19: First UK vaccine safety data are “reassuring,” says regulator. BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n363 (Published 08 February 2021)
… The UK’s medicines regulator has described the first safety data related to covid-19 vaccines as “reassuring,” with most side effects reported being mild and in line with those seen with other types of vaccine. “The benefits continue to far outweigh the risks,” said June Raine, chief executive of the Medicines and Healthcare Products Regulatory Agency (MHRA).
… The agency published yellow card data for covid-19 vaccines given between 9 December 2020 and 24 January 2021, which comprise 22 820 reports from 7 164 387 first doses and 474 156 second doses. Most of the reports (16 756) are from people who received the Pfizer-BioNTech vaccine, and these list 49 472 suspected reactions. Administration of the AstraZeneca-Oxford vaccine began later, on 4 January, and 6014 yellow cards were reported up to 24 January, detailing 21 032 suspected reactions. A further 50 yellow card reports did not specify the brand of vaccine.
… By 24 January an estimated 5.4 million first doses of the Pfizer-BioNTech vaccine and 1.5 million doses of the AstraZeneca-Oxford vaccine had been administered, and around 0.5 million second doses, mostly of the Pfizer-BioNTech vaccine. Overall, the data show around three yellow card reports per 1000 doses of the vaccine given—a smaller proportion than the 10% of patients reporting them in clinical trials.
…. Severe allergic reactions were reported after administration of the first doses of the Pfizer-BioNTech vaccine on 9 December. Subsequently, the MHRA advised against its use for people with a history of severe allergic reactions to any ingredients in the vaccine and said that recipients should be monitored for at least 15 minutes.
…. A total of 101 anaphylaxis or anaphylactoid reactions after the Pfizer-BioNTech vaccination (1-2 cases per 100 000 doses) have been reported to the MHRA up to 24 January, and 13 anaphylaxis reactions after the AstraZeneca-Oxford vaccine.
….. Bell’s palsy is listed as a possible side effect of the Pfizer-BioNTech vaccine, and facial paralysis or paresis after this vaccine was mentioned in 69 yellow card reports; facial paralysis was mentioned in six reports after the AstraZeneca-Oxford vaccine. Philip Bryan, vaccine safety lead at the MHRA, said, “Bell’s palsy is something that can also happen naturally, so its association with the vaccine hasn’t been established.”
… The MHRA received 107 reports of death after the Pfizer-BioNTech vaccine, 34 after the AstraZeneca-Oxford vaccine, and 2 in which the brand of the vaccine was unspecified. Most reports were for older people or people with underlying illness, the MHRA said, and a review of individual reports and patterns of reporting did not indicate that the vaccine played a role in the death. “We know, for instance, based on data from [the Office for National Statistics], that for every 100 000 doses given to people aged 80 or over, around 200 people die of natural causes within a week,” Bryan said.