With which COVID-19 vaccines will it be possible to enter Spain from Monday, June 7



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Iberia and Air Europa planes parked on the tarmac at Adolfo Suárez Barajas Airport (Reuters)
Iberia and Air Europa planes parked on the tarmac at Adolfo Suárez Barajas Airport (Reuters)

Spain is easing border restrictions due to the pandemic and will allow entry for tourists from Monday, June 7. The condition is that they have completed the vaccination cycle, with two doses in almost all existing vaccines, at least fourteen days before their trip. But it can’t be just any vaccineThose traveling must be immunized with one of the developments authorized by the European Medicines Agency (EMA) or the World Health Organization.

Yes indeed, the list is reduced to Pfizer, Moderna, AstraZeneca, Johnson & Johnson, Sinopharm y Sinovac. Of course, as the Spanish authorities have confirmed, the payroll will be widened as the EMA and WHO authorize more vaccines.

Pfizer

Pfizer's vaccine was the first approved by EMA and WHO
Pfizer’s vaccine was the first approved by EMA and WHO

The European Union approved the Pfizer / BioNTech vaccine in December against the coronavirus, which opened the door to the first vaccinations in the 27 member countries after the Holidays. The EMA cleared the product for commercialization and hours later the EU’s executive body, the Commission, gave the final green light. Almost in parallel, he received the green light from the WHO.

The vaccine developed by the American giant Pfizer and the German company BioNTech had shown, when approved, an efficacy of 95% in international clinical trials in which two doses were administered three weeks apart.

The regulator carried out a “continuous review” of data from laboratory analyzes and clinical trials as they arrived. Normally, the agency does not review the data until it has been fully collected.

The formula is based on messenger RNA technology, which contains DNA instructions that allow cells in the human body to generate certain protective proteins. 95% efficacy against the SARS-CoV-2 virus was achieved seven days after the second dose of vaccine and 28 days after the first.

Modern

Modera development has been in use in Europe since January 2021
The Modera development has been in use in Europe since January 2021

The EMA and WHO approved Moderna’s vaccine in January 2021. This vaccine, based on messenger RNA technology, was developed by a pioneering startup in anti-covid vaccines, it has characteristics similar to that developed by Pfizer-BioNTech, with an efficiency of 94.1%. Moderna’s formula, like Pfizer’s, should be frozen, but not so low, close to -20 degrees.

The vaccine is given as two injections into the arm, 28 days apart. The most common side effects of the vaccine were usually mild or moderate and improved within days of vaccination. These include pain and swelling at the injection site, fatigue, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting.

Oxford-AstraZeneca

(Reuters)
(Reuters)

The EMA gave the green light at the end of January for conditional use of the AstraZeneca vaccine and the University of Oxford in the European Union (EU) in January 2021 and the WHO followed suit in February this year .

This vaccine was developed by researchers at the University of Oxford in collaboration with the British pharmaceutical giant AstraZeneca. It is a “viral vector” vaccine: it is based on another virus (a chimpanzee adenovirus) which has been weakened and genetically modified to prevent the coronavirus from reproducing in the human body. The way it introduces genetic material into cells, ordering them to attack SARS-CoV-2, has been called a “Trojan horse”.

It has the advantage of being inexpensive (around 2.5 euros or 3 dollars a dose, with variations according to local production costs). AstraZeneca agreed to sell it for no profit. Too it is easy to store: it can be stored at the temperature of a refrigerator, between 2ºC and 8ºCunlike Moderna and Pfizer / BioNTech vaccines, which can only be stored for a long time at very low temperatures. This facilitates large-scale vaccination.

This drug is also distributed through the Covax program in developing countries.

Referring to the rare cases of thrombi in people immunized with this formula, the European Medicines Agency (EMA) said that “no causal relationship has been proven, but it is possible”, and the benefits of the coronavirus vaccine they have still outweigh the risks.

Johnson & johnson

FILE PHOTO: Illustration with labeled vials "COVID-19 coronavirus vaccine" and syringe in front of the Johnson & Johnson logo, February 9, 2021. REUTERS / Dado Ruvic
FILE PHOTO: Illustration with vials labeled “COVID-19 Coronavirus Vaccine” and a syringe in front of the Johnson & Johnson logo, February 9, 2021. REUTERS / Dado Ruvic

This vaccine was, in mid-March, the fourth to obtain authorization from the European Medicines Agency (EMA), after those of Pfizer-BioNTech, Moderna and AstraZeneca. WHO allowed it almost simultaneously.

The vaccine is supported by a viral vector, applying a technology already used by this company, in particular against the Ebola virus. In addition, it uses another attenuated virus as a vector, transformed to add genetic instructions for part of the virus responsible for covid-19. Once it reaches the cells, it produces a protein typical of SARS-CoV-2 (virus from the same family that caused severe acute respiratory syndrome in Southeast Asia in 2002-2004), which enables the system immune system to recognize it. This is the first single dose to receive authorization from the World Health Organization (WHO).

For the European Medicines Agency (EMA), the Johnson & Johnson COVID-19 vaccine can be used as the benefits continue to outweigh the risks. The European regulator considers that the thrombi suffered by some vaccinated people will be considered as a “very rare” side effect of this vaccine.

“The EMA recognizes a possible link with the very rare cases of unusual thrombi associated with low blood platelet counts,” the agency said, noting that this “confirms that the overall benefit / risk balance remains positive.”

The chief financial officer of Johnson & Johnson (J&J) had previously assured that the laboratory had “complete confidence” in the vaccine and hopes to find “quickly” a solution with the regulators for its use.

This is an important decision, as several European countries have thThis single-dose vaccine to speed up your vaccination campaign.

Sinopharm

The Chinese Sinopharm vaccine has been approved by the WHO but has not yet been approved by the European Medicines Agency.
The Chinese Sinopharm vaccine has been approved by the WHO but has not yet been approved by the European Medicines Agency.

Sinopharm is the first Chinese injectable to receive WHO approval and the sixth vaccine that he authorizes after having verified that it meets the required efficacy and safety criteria.

This approval will allow the COVAX platform for equitable access to vaccines to enter into negotiations with the company Sinopharm to acquire its vaccines and distribute them in countries that do not have access to them.

The WHO approval came after it was reported that this vaccine provides 65% protection for people under the age of 60 to prevent serious illness and complications from coronavirus infection. The expert committee recommended the vaccine for people over 18 years of age.

Clinical trials with the Sinopharm vaccine have been conducted in China, United Arab Emirates, Bahrain, Jordan, Egypt, Peru and Argentina. In Argentina, it was cleared for emergency use on February 21 by the Nation’s Ministry of Health.

First, it was allowed for people under 60. But, at the end of March, specialists who are part of the National Immunization Commission and the National Commission for Vaccine Safety maintained that there is sufficient evidence of its effectiveness and safety when also applied in vaccines. people over 60.

Regarding the efficacy of the vaccine, Preliminary results from phase 3 indicated that it offers 79.34% protection starting 14 days after receiving both doses.

Sinovac

On June 1, the World Health Organization (WHO) approved emergency use of the Sinovac vaccine, the second vaccine made in China to get the green light. after the one developed by Sinopharm.

Studies indicate that the Sinovac vaccine has a only 51% effective in reducing symptomatic cases of COVID-19, although the percentage rises to 100% for severe cases and those requiring hospitalization.

The Sinopharm and Sinovac vaccines are not authorized by the European agency but since they have the green light from the WHO, people vaccinated with them will also be able to enter Spain.

Spain has clarified that travelers from Brazil, India and South Africa will not be able to enter Spain due to the high incidence of covid-19 variants.

What will happen to those who have been immunized with Sputnik V

Illustrative image of flasks with label "Vacuna Sputnik V Coronavirus COVID-19".  March 12, 2021. REUTERS / Dado Ruvic
Illustrative image of vials labeled “Sputnik V Coronavirus COVID-19 Vaccine”. March 12, 2021. REUTERS / Dado Ruvic

At the moment Russian development it has not been authorized by the EMA. Its experts completed the Good Clinical Practice Inspection with Russian Development on May 13 and are now visiting its factories, while monitoring vaccination campaigns to determine how long vaccines are protected and whether third doses are needed.

The reports of the two inspections will be part of the final dossier of the Russian vaccine study, an ongoing evaluation process that could lead to a conditional use license in the EU.

Inspection of factories where vaccines are produced in Russia aims to ensure that “adequate standards and controls for a careful manufacturing process” are met and to ensure that there is “consistency in manufacturing of the product”. So far, there is no precise date to know the conclusion of these investigations.

However, at the WHO, the Russian inoculant, are in the final phase of evaluation. If in the coming weeks the world body decided to add it to the list, it would allow the millions of people vaccinated with the Russian vaccine – widely used in Argentina, for example – to travel to Spain as tourists.

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