The European Medicines Agency’s safety committee said on Friday it was reviewing reports of heavy menstrual bleeding and absence of menstruation from women who had received COVID vaccines from Pfizer (PFE.N)/BioNTech (22UAy.DE)and Moderna (MRNA.O).
The assessment was in view of reports of menstrual disorders after receiving either of the two vaccines, both based on messenger RNA technology, and it was not yet clear whether there was a causal link, the agency said.
In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is currently investigating six reported cases of capillary leak syndrome in people who were vaccinated with Spikevax, previously known as COVID-19 vaccine Moderna.
These six cases are out of over 61.6 million doses of the Moderna vaccine administered in the European Union and the European Economic Area (Norway, Iceland and Liechtenstein) and since it received authorization in January 2021. The EMA also pointed out that currently there is no evidence of a causal link between the Moderna vaccine and capillary leak syndrome.
Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.
The present assessment raises the question whether it would be necessary to rethink policies and use COVID-19 vaccines more sparingly and with some discretion only in those that are willing to accept the risk because they feel more at risk from the true infection than the mock infection. Perhaps it might be necessary to dampen the enthusiasm by sober facts? In our view, the EMA and national authorities should instigate a safety review into the safety database of COVID-19 vaccines and governments should carefully consider their policies in light of these data. Ideally, independent scientists should carry out thorough case reviews of the very severe cases, so that there can be evidence-based recommendations on who is likely to benefit from a SARS-CoV2 vaccination and who is in danger of suffering from side effects. Currently, our estimates show that we have to accept four fatal and 16 serious side effects per 100,000 vaccinations in order to save the lives of 2–11 individuals per 100,000 vaccinations, placing risks and benefits on the same order of magnitude.
Countries should also avoid giving the Astrazeneca coronavirus vaccine to people over 60, the head of the EU drug regulator’s COVID-19 task force was quoted on Sunday as saying, amid fears over rare blood clotting and as more vaccines become available. Emer McCarthy reports.
Launching a programme of Covid-19 immunisations for children should be considered only in special circumstances, leading health experts have warned.
They say UK medical authorities, who are currently studying how vaccines for adolescents might be administered, should move with great care over the implementation of such a programme.
Doctors are now being told to look out for signs of the most common type of stroke following the Oxford coronavirus vaccine, after three British patients were admitted to hospital and one died.
Two women in their 30s and a man in his 40s suffered ischaemic strokes after having the vaccine.
Previous reports of rare blood clots from the jab have specifically involved cerebral venous thrombosis – a rare form of stroke caused by the blockage of specific veins.
A presentation made to the National AEFI (adverse event following immunisation) Committee on March 31 recorded that there had been 180 deaths till that time and three-fourths of the deaths happened within three days of the shot.
In other serious adverse events too, the overwhelming majority took place in the three-day window. Even as AEFI deaths are reported daily, causality assessment by the National AEFI Committee appears to be lagging with information about just 10 deaths in the public domain.
One of the European drug regulator’s senior officials today claimed there is now a ‘clear’ link between AstraZeneca’s Covid vaccine and potentially deadly blood clots.
Marco Cavaleri, head of vaccines at the European Medicines Agency (EMA), said that CVST — a brain blockage that can lead to a stroke — was occurring more often than expected in younger people.
..The UK’s safety watchdog, the MHRA, has so far spotted 30 rare clotting events in 18.1million doses – around one in every 600,000. But the EMA believes it may occur in up to one in every 100,000 under-60s.
Michael Yeadon was a scientific researcher and vice president at drugs giant Pfizer Inc. He co-founded a successful biotech. Then his career took an unexpected turn.
In conclusion, the observed safety profile is considered favourable. Longer term safety data is awaited
from the ongoing clinical trials.
There are very limited data on the use of the vaccine in immunocompromised individuals and on use in pregnancy and breastfeeding. No data was generated with mRNA-1273 when administered concomitantly with other vaccines.
The CHMP considers the following measures necessary to address the missing safety data in the
context of a conditional MA:
The final clinical study report will be submitted no later than December 2022 and is subject to a specific obligation laid down in the MA. This will provide long-term data.
We note that a wide range of side effects is being reported following vaccination of previously healthy younger individuals with the gene-based COVID-19 vaccines. Moreover, there have been numerous media reports from around the world of care homes being struck by COVID-19 within days of vaccination of residents. While we recognise that these occurrences might, every one of them, have been unfortunate coincidences, we are concerned that there has been and there continues to be inadequate scrutiny of the possible causes of illness or death under these circumstances, and especially so in the absence of post-mortems examinations.
Germany has recommended the AstraZeneca coronavirus vaccine should only be given to people under the age of 65, according to reports.
The country’s vaccine committee has reportedly said the jab, developed alongside the University of Oxford, should only be offered to people aged between 18 and 64.
It gave a lack of sufficient data on the effectiveness of the inoculation in older people as the reason for the decision in a draft recommendation.