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(CNN Español) – The UK on Wednesday approved the use of Pfizer and BioNTech vaccine against the coronavirus, which implies a big step in the eventual vaccination of high-risk populations and in containing the advance of the pandemic around the world.
Here’s what you need to know about the Pfizer and BioNTech vaccine.
95% effectiveness
On November 9, Pfizer announced that its vaccine candidate had achieved more than 90% effectiveness in preventing infection with the novel coronavirus in its Phase 3 study.
Subsequently, on November 20, the company said its latest analysis of its data revealed that its vaccine efficacy had reached 95 percent.
In a press release, Pfizer said Phase 3 of its vaccine study showed 170 cases of Covid-19 occurred among more than 43,000 volunteers. Half of those volunteers received the vaccine and the other half the placebo.
Of the cases, only 8 occurred among people who received the vaccine and 162 among those who received placebo.
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Design using messenger RNA
Pfizer and its Germany-based partner BioNTech are using a new approach to make vaccines that use messenger RNA, or mRNA.
This design was chosen years ago for a pandemic vaccine because it is one that lends itself to a quick response. All you need is the genetic sequence of the virus causing the pandemic. Vaccine makers don’t even need the virus itself, just the sequence.
In this case, the BioNTech researchers used a small piece of genetic material that encodes a fragment of the spike protein, the structure that adorns the surface of the coronavirus, giving it that studded look.
Messenger RNA is a single strand of the genetic code that cells can “read” and use to make a protein. In the case of this vaccine, mRNA instructs the body’s cells to produce the specific part of the virus spike protein. The immune system then sees it, recognizes it as foreign, and is ready to attack when an actual infection occurs.
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Need for ultra-cold storage
MRNA is very fragile, which is why it is wrapped in lipid nanoparticles, a layer of a buttery substance that can melt at room temperature.
This is why Pfizer’s vaccine needs to be kept in ultra-cold temperatures of around -75 degrees Celsius.
In other words, the transportation and storage of this vaccine requires special equipment.
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UK Approval
In a statement, the UK Department of Health (NHS) said it had “accepted the recommendation of the Independent Medicines and Health Products Regulatory Agency (MHRA) to approve” the vaccine, after “months of rigorous studies. clinical and extensive data analysis by MHRA experts who concluded that the vaccine met their rigorous standards of safety, quality and efficacy.
According to the statement, the vaccine will be available across the UK from next week.
And he says that “the NHS has decades of experience in implementing large-scale vaccination programs and will begin implementing its extensive preparations to provide assistance and support to all people eligible for vaccination.”
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Pending US Emergency Use Authorization
On November 20, Pfizer and BioNTech submitted documentation to the U.S. Food and Drug Administration (FDA) to obtain an Emergency Use Authorization (EUA) for their COVID-19 vaccine. 19.
“This is a historic day, a historic day for science and for all of us,” said Albert Bourla, Pfizer CEO, in a video shared on Friday.
“It took only 248 days from the day we announced our plans to partner with BioNTech to the day of our submission to the FDA. We have operated at breakneck speed in our clinical development program, from concept to regulatory filing, always keeping our focus on safety, ”said Bourla.
Pfizer candidate was the first coronavirus vaccine to seek regulatory approval in the United States. Moderna also applied for an EUA from the FDA, after announcing 94.5% effectiveness.
Pfizer and BioNTech said in a statement that their vaccine candidate, known as BNT162b2, could potentially be available for use in high-risk populations in the United States from mid to late December.
As explained by Dr Elmer Huerta, “in the interest of gaining greater transparency and scientific weight in its decisions, the FDA convenes US and international expert groups to help it make final decisions.”
The FDA will meet its Advisory Committee on Vaccines and Related Biological Products, an external expert panel, for December 8, 9, and 10. So a source familiar with the trial told CNN.
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The agency could make a decision at the end of the December 10 meeting on whether to issue an emergency use permit, the source said.
FDA (USA) emergency use authorization is not the same as full approval.
An EUA allows products to be used in special circumstances before all the tests required for type approval are available.
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