Madrid / The speed of spread of the new variant of coronavirus detected in the United Kingdom has led Spain to suspend all flights with this country except for Spaniards and residents, although it is not expected to modify the effectiveness of the vaccine that is already endorsed by the European Medicines Agency.
Following the approval of the EMA to the Pfizer / BioNTech drug after confirming its safety and efficacy, the European Commission has authorized its conditional commercialization, with which Spain will already be able to start vaccinating inmates and health and social-health personnel from next Sunday. residences for the most vulnerable elderly and large dependents and all those who work in them.
However, this milestone, as the director of the Spanish Medicines Agency (AEMPS), María Jesús Lamas, has described, has been clouded by the appearance of a new strain in the United Kingdom whose ease of spread has triggered all the alarms.
To date there is no evidence that it is present in Spain, although this does not mean that it is not, explained the Minister of Health, Salvador Illa, who has warned that our country may be at the “beginning of the third wave” after verifying “clearly” the change in trend with respect to the bend in the curve.
Not surprisingly, today the incidence accumulated at 14 days has undergone a new rise to 224.88 cases per 100,000 inhabitants; In its balance today, the Ministry of Health has recorded 22,013 new positives for coronavirus since last Friday, bringing the total number of infections to 1,819,249.
“We are especially expectant. We are going to follow from the National Epidemiology Center and the Health Alerts and Emergencies Coordination Center with special attention to everything that is related to this new variant in every way ”, added later its number two, the Secretary of State for Health, Silvia Calzón.
Cancellation of flights and more controls in Gibraltar
Given the speed of the British variant, the Spanish Government has ended up canceling flights with the island except for Spanish citizens or residents, as other European countries had announced throughout the morning.
The decision was taken after the need to adopt coordinated measures was exposed in Brussels, as Spain claimed yesterday, Moncloa specified.
The Executive has made this decision in concert with Portugal after the meeting of the EU crisis mechanism, which today analyzed the effects of the new strain of coronavirus detected in the United Kingdom and has asked that non-essential travel be avoided.
At the same time, it will reinforce controls at the Gibraltar border crossing, where its main minister, Fabian Picardo, has reported that a patient manifested the new coronavirus strain last November, although he has admitted that, as in the rest of Europe , can not say with certainty if the variant circulates or not through the Rock.
The effectiveness of the vaccine
What does not seem at the moment is that this strain will affect the effectiveness of the vaccine that is about to be supplied throughout the EU.
“Not necessarily the variations will imply modification of the effectiveness of the vaccine. Vaccines are directed at protein S, and no variation has had significant changes in its structure, “argued Lamas, who specified that a clinical trial will not be necessary to verify it, but only” laboratory tests. “
The Committee for Medicinal Products for Human Use (CHMP) of the EMA, made up of experts from the competent authorities of the different member states, including the AEMPS, has concluded by consensus that there is sufficiently robust data on “ quality, safety and efficacy ”of Pfizer’s medicine.
Comirnaty, which prevents the disease caused by SARS-CoV-2 from the age of 16, consists of two injections in the arm 21 days apart.
Adverse reactions to the vaccine
The most frequent adverse reactions, specified the AEMPS, have been mild or moderate and improved after a few days after vaccination; among them, pain and inflammation in the injection site, fatigue, headache, muscle and joint pain, chills and fever, “very common” all in vaccines, according to Lamas.
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.
“It is very important to remember that there will be a temporal relationship between many adverse effects and the administration of the vaccine, but they do not have to be related to each other,” added the head of the AEMPS.
A drug that has been shown to be 95% effective in protecting against covid; 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 clinical trial
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 remains for us is how long the immunity will last, as well as how much it protects against serious disease. We will see it 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 ”, Lamas concluded. (December 21, 2020, EFE / PracticaEspañol)
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