The director of the Spanish Medicines Agency (Aemps), María Jesús Lamas, explained this Monday that the side effects associated with the administration of the Pfizer vaccine such as pain at the site of the puncture, muscle or head pain, and fatigue are “very usual “with vaccines.
“The most frequent reactions that have appeared are pain at the injection site, tiredness, headache, muscle aches or cramps, joint pains, fever in a much lower percentage or inflammation at the injection site. These reactions are very habitual in vaccines ” , has emphasized in a joint press conference with the Secretary of State, Silvia Calzón .
Meanwhile, other “rarer” that have occurred with a “much lower” frequency have been difficulties sleeping, nausea and, in four cases in which the causal relationship could not be established but “it must be borne in mind” , a mild facial paralysis.
Lamas spoke after the European Medicines Agency (EMA) gave its endorsement to the Pfizer / BioNTech vaccine prior to the marketing authorization that the European Commission will give shortly.
The European Commission approves the marketing of the Pfizer and BioNTech vaccine against Covid-19 in the EU
A drug that has been shown to be 95% effective in protecting against Covid , regardless of age and for mild and severe cases , although, on the latter, it has specified that more study time will be necessary.
Efficacy has been estimated in more than 36,000 volunteers over 16 years of age (including people over 75) who did not show signs of previous infection; The study with more than 44,000 volunteers has shown a reduction in the number of symptomatic cases of coronavirus in people who received the vaccine.
A total of eight cases out of 18,198 developed symptoms compared to 162 cases out of 18,325 showing symptoms in the placebo group, leading to the claim that the vaccine has been shown to be 95% effective in the clinical trial.
A trial that has also shown around 95% efficacy in participants at high risk of developing severe symptoms , including those with asthma, chronic lung disease, diabetes, hypertension, or a body mass index of 30 kg / m2; this efficacy index has also been maintained between ethnicities and sexes.
” What we have left to know is how long the immunity will last , as well as to what extent it protects against severe disease. We will see that as the studies continue, which in phase three last up to three years. There is not enough data to say that there is no risk for pregnant women, “he noted.
Once the European Commission gives the green light to the marketing of the drug, it will begin its distribution in the member countries of the EU, which will receive the first doses on Saturday.
The Emergency Medical System (EMS) and frontline healthcare workers in the US are being vaccinated against Covid-19 with the Pfizer-BioNTech vaccine.
Getting vaccinated against Covid will be voluntary, but Health will register those who refuse to be immunized
Spain still does not know which ones will arrive, nor does it know how many will correspond to each community: “In these hours the exact delivery of the number of doses is being finalized . In a few hours we will have more concreteness,” the secretary replied. State of Health.
It is also the communities that have organized the process, which in this first stage will not require a prior appointment since the first to be immunized will be the inmates in residences for the elderly and large dependents , their workers and first-line health personnel.
Regarding the people who refuse to be vaccinated and who will be included in the vaccination registry , the number two of Health has replied that “it may be of interest to help us analyze what are the reasons why it is rejected and insist on information campaigns and outreach to stress the importance of vaccines. “
Because, he concluded, “it is important to remember two aspects: one, none of us are immune” and “two, the concept of vaccination is a gesture of solidarity “. “We must stop the transmission,” he has settled.