The vaccination campaign has extended worldwide. Specifically, more than 74 Million people have been fully vaccinated in the U.S. Only a very limited number of individuals have shown severe reactions, all of them quickly resolving (most of such persons had significant previous allergic preexisting conditions).
Also, although the evaluation of the vaccines against COVID-19 by the regulatory agencies (FDA, EMEA, UK) has been extremely rapid, it is important to emphasize that there have been no “short cuts” in the development of the SARS-CoV-2/COVID-19 vaccine. In fact, the overall procedure has been exactly the same as compared with other vaccine evaluations. In particular, the number of individuals included in the studies compares well with previous evaluation procedures. Also, it is important to note that the companies had transferred their preliminary data to the regulatory agencies in advance and thus the evaluations have been performed on a stringent basis.
A few people have experienced rare types of blood clots after receiving the Oxford-AstraZeneca vaccine, particularly, in Europe, where the AstraZeneca vaccine is widely used. The European Medicines Agency (EMA) has concluded that the Oxford–AstraZeneca COVID-19 vaccine should carry a warning that blood clots, accompanied by low levels of blood platelets, are very rare side effects of the vaccine. Vaccinated people and health-care providers should be aware of blood-clot symptoms, such as shortness of breath, chest pain, leg swelling and persistent abdominal pain, to ensure prompt treatment. However, EMA along with the World Health Organization (WHO) and the Medicines and Healthcare products Regulatory Agency (UK) have stated that the benefits of vaccine still greatly outweighed the risks.
Because of its safety concern, Germany, the Netherlands, the Philippines, Portugal and Spain have recommended vaccination of this vaccine only to people over 60. Canada and France have limited it to those over 55; Australia, over 50; Belgium, over 56. Regulators in France and Germany have recommended that people under 55 who have had one dose get a different vaccine for their second shot. Britain would begin offering alternative shots to people under 30.
On Tuesday, April 13, the US Food and Drug Administration and the Centers for Disease Control Federal health agencies called for an immediate pause in the use of the Johnson & Johnson vaccine after six recipients in the US developed a rare disorder involving blood clots within about two weeks of vaccination. The agencies are currently evaluating its safety.