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The United Kingdom is the first country in the world to have authorized the administration of Pfizer-BioNTech vaccine for the prevention of coronavirus. The European Medicines Agency has taken critical positions against this decision. However, the Boris Johnson executive is rapidly advancing his mission and has announced that the first doses will be injected next week. Meanwhile, the first informational documents on the Pfizer vaccine have been posted on government websites, which also contain the contraindications, andIndependent reveals there would be one immunity clause against legal action if something goes wrong during administration.
“The government has accepted the recommendation of the Kingdom’s pharmaceutical regulatory authority, the MHRA, to approve the use of Pfizer-BioNTech’s Covid-19 vaccine.”, Reads the note from the Ministry of Health. The United Kingdom has chosen to approve it in modality continuous review, which allows you to complete an ongoing medication assessment in the event of an ongoing health emergency. The UK has currently ordered 40 million doses, useful to vaccinate 20 million people, but more will arrive by the end of the year. The procedure is not a UK prerogative due to Brexit, but it is up to each European Union state to use this emergency procedure for the distribution of the vaccine for temporary use prior to EMA approval. The decision of the European Medicines Agency is expected to arrive on December 29: “A few weeks of in-depth examination by the EMA is better than a ‘hasty clearance put a vaccine on the marketThese are the words of Peter Liese, MEP representing the CDU in Brussels.
The document called “Information for Healthcare Professionals about the Pfizer BioNTech Covid-19 Vaccine” indicates the basic information about the BNT162b2 vaccine, with technical specifications, methods of use and any contraindications and side effects. In this sense, point 4.6 deals with the issue of pregnancy, fertility and breastfeeding. In particular, the document states that “Data on the use of the COVID-19 BNT162b2 mRNA vaccine do not exist or are limited. Reproductive toxicity studies in animals have not been completed. The COVID-19 BNT162b2 mRNA vaccine is not recommended during the the pregnancy. For women of childbearing potential, pregnancy should be excluded before vaccination. In addition, women of childbearing potential should be advised to avoid pregnancy for at least 2 months after the second dose.“. The document released by the government also specifies that”it is not known whether the COVID-19 mRNA BNT162b2 vaccine has an impact on Fertility“A similar argument is also made for the lactation period, because”it is not known whether the COVID-19 mRNA BNT162b2 vaccine is excreted in human milk“. For this reason “I risks for babies / children can not be excluded“, so its use is not recommended during lactation.
Meanwhile, the British government would have “awarded the pharmaceutical giant Pfizer a ‘legal compensation to protect you from being sued by allowing your coronavirus vaccine to be rolled out nationwide next week“The Independent, which reports that the Department of Health and Welfare has confirmed that Pfizer will be protected in case legal action is taken after any vaccine problem. Interviewed by journalists at Wednesday’s press conference,” Chief Executive Officer from Pfizer in the UK would not have explained why the company needed the allocation.
