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(CNN Spanish) – The United Kingdom began to administer the Pfizer and BioNTech vaccine against the coronavirus on Tuesday, which implies a great step for the eventual vaccination of high-risk populations and in containing the advance of the pandemic in the world.
Here’s what you need to know about the Pfizer and BioNTech vaccine.
95% effectiveness
On November 9, Pfizer announced that its candidate vaccine had achieved, in its phase 3 study, more than 90% effectiveness in preventing infection with the new coronavirus.
Later, on November 20, the company said that the latest analysis of its data revealed that the effectiveness of its vaccine had reached 95%.
In a press release, Pfizer said that phase 3 of its vaccine study showed that 170 cases of Covid-19 occurred among the 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 the people who received the vaccine and 162 among those who received the placebo.
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Design via messenger RNA
Pfizer and its German-based partner BioNTech are using a new approach to making vaccines that uses messenger RNA, or mRNA.
This design was chosen for a pandemic vaccine years ago because it is one that lends itself to a rapid response. All that is needed is the genetic sequence of the virus causing the pandemic. Vaccine manufacturers 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 appearance.
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, the mRNA instructs the cells of the body to produce the specific part of the spike protein of the virus. The immune system then sees it, recognizes it as foreign, and is ready to attack when an actual infection occurs.
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Mexico signs an agreement with Pfizer to obtain 34.4 million vaccines against the coronavirus
The Government of Mexico signed an agreement last week with the pharmaceutical company Pfizer to obtain 34.4 million vaccines against the coronavirus, the Ministry of Health reported in a message posted on Twitter.
In another publication, the Secretariat said that “the expectation is to receive 250,000 doses this month to protect Mexicans, with priority on health personnel who are on the first line of care for this disease.”
Need for ultra-cold storage
The mRNA is very fragile, so it is enveloped in lipid nanoparticles, a layer of a buttery substance that can melt at room temperature.
That is why Pfizer’s vaccine must be kept at ultra-cold temperatures of approximately -75 degrees Celsius.
In other words, transporting and storing this vaccine requires special equipment.
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UK approval
In a statement on 2 December, 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 clinical trials and extensive data analysis by MHRA experts who have concluded that the vaccine has met their stringent standards for safety, quality and efficacy.”
According to the statement, the vaccine would be available throughout the UK from the week following the announcement.
And he says that “the NHS has decades of experience in implementing large-scale vaccination programs and will begin to implement its extensive preparations to provide care and support to all people eligible for vaccination.”
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Waiting for authorization for emergency use in the United States
On November 20, Pfizer and BioNTech submitted to the US Food and Drug Administration (FDA) documentation 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 Pfizer CEO Albert Bourla in a video shared Friday.
“It took just 248 days from the day we announced our plans to collaborate with BioNTech to our submission day to the FDA. We have operated at extraordinary speed in our clinical development program, from concept to regulatory filing, always maintaining our focus on safety, “said Bourla.
The Pfizer candidate was the first coronavirus vaccine to seek regulatory approval in the United States. Moderna also requested an EUA from the FDA, after announcing an effectiveness of 94.5%.
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 in mid-to-late December.
As explained by Dr. Elmer Huerta, “in order to achieve greater transparency and scientific weight in its decisions, the FDA convenes groups of US and international experts to help it make its final determinations.”
The FDA has a meeting of its Advisory Committee on Vaccines and Related Biologics, a group of outside experts, scheduled for December 8, 9 and 10. So a source familiar with the process told CNN.
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The agency could make a decision at the end of the meeting on December 10 on whether to issue an emergency use authorization, the source said.
FDA Emergency Use Authorization (US) is not the same as full approval.
An EUA allows products to be used in particular circumstances before all the necessary tests for approval are available.
