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6 Questions About UK Approval of Pfizer and BioNTech Vaccine | The State

Never has a vaccine taken such a short time to be developed and licensed for public use.

This Wednesday, 10 months after the pandemic broke out, UK approved the vaccine from Pfizer and BioNTech against coronavirus.

It was the first country in the world to take that step, although other bodies are expected to make decisions about it soon.

In the United States, the Food and Drug Administration (FDA) will decide whether or not to approve the vaccine as of December 10. Its counterpart in Europe, the European Medicines Agency (EMA), has scheduled it on the 29th of this month.

Following the UK announcement, the European Union (EU) defended your caution, ensuring that its process is based on a more exhaustive analysis of evidence than that of the United Kingdom, in a line similar to that expressed by the US health authorities.

“The United Kingdom has not done it as carefully as we have,” defended Anthony Fauci, chief scientist of the special team against the coronavirus of the White House, in statements to Fox News, although he later apologized, assuring that he trusted the criteria of British authorities.

From the government of London they affirm that the vaccine is ready, that its use is safe and that they have complied with all the steps of the process to guarantee it. In fact, the country plan to start vaccinating to starting next December 7.

As the world watches closely for the first national vaccination campaign against covid-19, several questions arise.

Why did the UK make this decision before anyone else? How quickly will the British achieve immunity?

BBC Mundo answers these and other questions.

1. Why did the United Kingdom approve the vaccine before the European Union or the United States?

British Health Minister Matt Hancock says that Brexit – the UK’s exit from the EU – facilitated the decision.

But UK continues to abide by EMA regulations to the endto the transition period, which ends on January 1.

European legislation maintains that vaccines are authorized by the EMA, but states that any country can request a emergency procedure that allows them to temporarily distribute them in their domestic market.

June Rain, chief executive of the British drug regulator, said they authorized the vaccine under European law. (Photo: Getty Images)

Dr June Raine, chief executive of the UK Medicines and Health Products Regulatory Agency (MHRA), said Wednesday that they “authorized the supply of the vaccine under European law, effective until next January 1. from January”.

Raine assured that the work of the British MHRA corresponds to “international standards” and that, despite being the first to approve the vaccine, they have not skipped any steps.

“Our speed or progress was based entirely on the availability of data during our regular evaluation, and a rigorous review and independent advice we received,” he said Wednesday.

2. Did the UK rush into its decision as Fauci says?

In the midst of the difficult situation that many countries are going through due to the pandemic and the benefits of starting with vaccination, politicians from other countries came out to defend their greater caution and some scientists, such as Anthony Fauci, in the US, they came to consider that London had rushed.

The UK “really rushed in with its approval,” Fauci, director of the US National Institute of Allergies and Infectious Diseases, told CBS.

“The way the FDA works, the way it is doing it, is correct,” the expert defended in another interview on Fox News.

“The idea is not to be the first but have a safe and effective vaccineGerman Health Minister Jens Spahn said at a press conference.

The European EMA explained in a statement that it used a method slower than the United Kingdom to approve vaccines and considered that its procedure is the “most appropriate mechanism in the current pandemic emergency.”

Pfizer / BioNTech Vaccine
The Pfizer / BioNTech vaccine took just 10 months to develop. (Photo: Getty Images)

As the BBC Health Correspondent Naomi Grimley explains, the FDA’s mechanism is “different from other agencies in the world.”

“He often asks vaccine manufacturers for their raw information and spends time re-analyzing it,” says Grimely.

The organization in London, for its part, “relies more on the reports of the companies themselves, as is the case with the European EMA, based in Amsterdam.”

However, the policy may also explain why the FDA has notbía given the green light, says the correspondent.

“In October, President Trump lobbied health authorities to approve the first vaccine candidates before Election Day. [3 de noviembre], but they resisted it, fearing that it could become politicized ”.

The FDA stated that it wanted to review additional data on the final phase of the trials before the drug companies could receive an emergency approval.

“Inevitably that led some to argue that the US had been embroiled in a review More detailed than necessary ”.

However, UK officials estimate that both Washington and Brussels will give their approval soon, the journalist said.

3. What can be the side effects of the vaccine and why does the UK defend that it is safe?

Most of the adverse effects of the Pfizer and BioNTech vaccine are mild, similar to those of other vaccines, and typically last no more than a day, according to Professor Munir Pirmohamed, chairman of the UK Commission for Human Medicine.

These can include muscle aches and a slight rise in temperature.

Boris Johnson, Prime Minister of the United Kingdom, during a visit to a laboratory.
The speed with which the UK approved the vaccine has been subtly questioned by the European Union. (Photo: Getty Images)

The Pfizer vaccine has been shown to be 95% effective in all age groups tested, including the elderly.

Britain’s internationally renowned MHRA has been reviewing preliminary data on vaccine trials since June and said the approval process was thorough.

“No vaccine would be licensed for distribution in the UK unless the expected standards in safety, quality and efficacy are met“, They stressed from the organism.

4. Who will be the first to get vaccinated?

Similar to other countries with vaccination plans, the UK will prioritize certain population groups.

First, it will be the elderly in nursing homes and their caregivers, then those over 80 years of age and health personnel, and from then on all age groups over 50 will be vaccinated.

Jonathan Van-Tam during Tuesday's press conference.
Jonathan Van-Tam, medical adviser to the British government, clarified that protection measures will continue until it is ensured that vaccination is reducing the cases of coronavirus. (Photo: Getty Images)

Those between the ages of 16 and 64 will also be prioritized be in risk groups due to previous ailments.

Dr Simon Stevens, chief executive of the British national health service, is confident that the vaccination of the first group will be completed in December.

According to the UK Joint Committee on Vaccination and Immunization, priority groups include the 90-99% of the population at highest risk.

The older you are, the more likely you are to become seriously ill or die from the virus. This risk increases considerably after the age of 70. People with previous ailments are also more vulnerable, experts say.

After the initial phase, which includes nine different groups, a second phase of vaccination will begin for more young people.

5. How quickly is immunity achieved with the Pfizer and BioNTech vaccine?

In total, around one month.

The Pfizer and BioNTech compound is given in two doses 21 days apart, and full immunity is not achieved until about a week after the second dose, explained Jonathan Van-Tam, medical adviser to the British government.

How long does it take for immunity to build after being vaccinated with the Pfizer and BioNTech compound

But according to the specialist, “neither can total protection be ensured for each person. It will depend on each case ”, he explained to BBC Radio 5.

Other vaccines pending approval also require two doses, such as Moderna and Oxford University and AstraZeneca.

6. How long will the restrictions last once the vaccination begins?

The United Kingdom has just completed its second national lockdown. Now it imposed a system of levels of restrictions according to the incidence of the virus in each region of the country.

But starting to vaccinate does not mean the end of these measures.

“Until we verify that the vaccine is working and that the numbers are falling, it is very likely that the protection restrictions will continue for a while. We need to be very safe before we tell people that they can relax, “Van-Tam told a news conference on Wednesday.

Clinical trials by Pfizer and other vaccine manufacturers have been shown to protect people from becoming seriously ill from the new coronavirus, but whether they also stop transmission is still unknown.

How Vaccines Compare in Phase III Clinical Trials

On the other hand, experts consulted by BBC Mundo point out that to start talking about a supposed normality, first 70% population immunity must be achieved.

Some predictions in the UK or Spain, for example, they hope to achieve these percentages between spring and summer 2021.

But experts warn that to return to complete normality, the percentages must be given in the entire world population. This can take several months and even years, especially in countries with fewer resources or developing.

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