Pfizer and BioNTech Vaccine – UK Approval Details – Health



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And one day, less than a year after China reported the first cases, the first coronavirus vaccine was approved in the West. The UK government announced on Wednesday that authorized the Pfizer / BioNTech covid-19 vaccine, which will be available from “next week.”

(You may be interested: Vaccine at all costs: reflections after days of intense public debate).

In clinical trials, reported in recent weeks, this vaccine proved to be 95 percent effective and with good results for everyone, young and old alike.

The government today accepted the recommendation of the Independent Agency for the Regulation of Medicines and Health Products (MHRA) to approve the use of the Pfizer / BioNTech covid-19 vaccine, ”said a ministry spokesperson.

With this news, the United Kingdom becomes the first country in the West to authorize a pharmacological treatment to prevent against covid-19. In fact, the British government revealed the purchase of a total of 40 million doses with which it will be able to vaccinate about 20 million people that will be prioritized in the coming days.

(Also: Guilds ask that COVID-19 vaccine decisions be made together).

“The approval follows months of rigorous clinical trials and extensive data analysis by MHRA experts”
said a statement released by the Ministry of Health.

Regulatory agency experts “concluded that the vaccine meets strict levels of safety, quality and effectiveness,” the note added.

The so-called Joint Committee on Vaccination and Immunization (JCVI) is now expected to publish its recommendation on which groups will be the first to receive the vaccine, but it is supposed to be the elderly and health workers.
With almost 59,000 deaths confirmed by covid-19, the United Kingdom is the country most affected in Europe by the pandemic, which this year will cause the largest setback in its economy in 300 years: -11.3%.

(You can also read: What do the first results of the seroprevalence study leave?).

England’s 56 million people came out of a second four-week lockdown but only to find themselves under local restrictions that will prevent them from seeing family and friends indoors and will keep bars, restaurants, cinemas and theaters closed in half the country.

In that sense, The UK on Wednesday envisioned the beginning of a gradual return to normalcy by becoming the first Western country to approve a coronavirus vaccine.

(You may be interested: Thanks to technology, ICU patients in Guainía overcame COVID).

“It is the protection of vaccines that will ultimately allow us to get our lives back and get the economy going again,” said British Prime Minister Boris Johnson, calling the approval for his use of the vaccine “fantastic.” covid-19 from Pfizer and BioNTech.

June Raine, executive director of the MHRA, told a press conference that there was no rush in her recommendation to approve the use of this vaccine. To buy time the agency used overlapping trials and “ongoing reviews” in its decision process. but all the security protocols were respected, he assured.

The challenges

In time with this historic announcement, the UK announced that it already has 50 hospitals ready to start vaccinating next week. The Minister of Health, Matt Hancock, told SkyNews that, in addition to hospitals, Special centers are being set up for vaccinating, as well as in neighborhood medical centers and pharmacies.

Even so, the minister warned of the difficult conditions to maintain the doses, 70 degrees below zero. “This is a challenging process and the NHS (Public Health) across the UK is ready … they are used to dealing with vaccines and drugs like this, with these kinds of conditions,” he added.

“It is not easy but we have plans, so this morning I speak with my colleagues from the other regions (Scotland, Wales and Northern Ireland) to ensure that we are all prepared to vaccinate starting early next week “, he indicated.

The centers will also be prepared to vaccinate with the dose developed by the University of Oxford and the British pharmaceutical AstraZeneca, which is evaluated by the regulatory body, the Medical and Health Products Regulatory Agency (MHRA).

The vaccine

The North American pharmaceutical company and its German ally Biontech, gave a historic coup on November 9, announcing, based on preliminary data, that the effectiveness of their vaccine was 92 percent and 10 days later, with other final results, they announced that the effectiveness reached 95 percent, even in older people, in addition to not triggering serious side effects.

But For the vaccine to reach the people, Pfizer and its partner have to overcome a series of challenges that according to their own announcements, they begin by preventing it from falling apart on the way.

As this vaccine is based on a synthetic piece of genetic material of the virus (mRNA) that causes defense reactions in the human organism, it decomposes unless it is kept refrigerated at temperatures below minus 70 degrees Celsius, which, in In the words of the health-care worker Elizabeth Beltrán, it requires enormous logistics never before deployed for its transport and storage.

Also, since there are two doses, Make sure people complete the scheme within 3 weeks, which can be complex. However, some months ago agreements began to be signed to reserve large quantities of the vaccine.

Donald Trump separated 100 million doses for delivery in December for 1.9 billion dollars, and signed an option to purchase another 500 million doses for the first half of 2021. Japan contracted 120 million doses and the European Union, 200 million so far.

(We recommend: Europe decides on the first covid-19 vaccine before December 29).

For this purpose, Pfizer and BioNtech expect to have 1,300 million doses ready by the end of 2021 and for this purpose, in parallel with the development of the project, they have already started mass production. at its plants in Andover (Massachusetts), Kalamazoo (Michigan) in the United States and in Puurs (Belgium), with the support of BioNtech in Germany, which will be part of the commercial supply network.

HEALTH UNIT

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