The United Kingdom became the first Western country to authorize a COVID-19
vaccine on Wednesday, marking a crucial moment in the global fight against coronavirus.
The Pfizer / BioNTech vaccine received an emergency clearance from British regulators and the first doses are expected to be rolled out early next week.
Britain has been one of the countries hardest hit by the pandemic, with the highest death toll in Europe, and its government has come under fire for its handling of the crisis.
But now it has overtaken both the European Union and the United States with this announcement.
Here is what you need to know about how you authorized the vaccine:
Why was the UK the first?
The vaccine received emergency clearance in the UK from its independent regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), which has played a crucial role in the process.
The MHRA began an ongoing review of the Pfizer and BioNTech data beginning in October, and each data “package” was reviewed as soon as it became available. This allowed regulators to examine the data in detail before submitting a final authorization request.
According to the MHRA, an ongoing review “can be used to complete the evaluation of a promising drug or vaccine during a public health emergency in the shortest time possible.”
This approach helped speed up the authorization process and a formal review of all the necessary information began in the UK on 23 November, leading to the announcement on Wednesday.
“I think the benefit is that the MHRA has been conducting ongoing review, which means that as Pfizer accumulated data on how they made the vaccine … MHRA could keep up,” David Salisbury, Associate Member of Health Chatham House Global. Program, he told CNN. “That has allowed the MHRA to be agile and keep up.”
The European Medicines Agency (EMA) is using a similar continuous review approach. The EMA began its review process of Pfizer data on October 6 and BioNTech and Pfizer submitted a request to complete the review process on December 1. The EMA has said it will conclude its review on December 29 at the latest.
EU member states cannot distribute COVID-19 vaccine until it has been authorized by the EMA and approved by the European Commission, in accordance with the EMA regulations.
The European Commission (EC) would need a few days to prepare the legal documentation and discuss the authorization decision with member states, according to an EC spokesperson.
“The fact that the MHRA was able to do this quickly will be a reflection of the rate at which Pfizer interacted with them,” Salisbury added.
In addition to the UK and the EU, Pfizer has also applied to the US Food and Drug Administration (FDA) for emergency use authorization for its candidate vaccine. The application was submitted on November 20.
FDA’s Advisory Committee on Vaccines and Related Biologics, a panel of independent experts, will meet on December 10 to discuss Pfizer’s application.
According to a US Operation Warp Speed document obtained by CNN on Tuesday, the first shipments from Pfizer coronavirus The vaccine will be delivered on December 15, if emergency authorization is granted.
BioNTech Medical Director Özlem Türeci said the company expected responses from the EMA and FDA by mid-December.
Türeci said Wednesday that the ongoing review process played “an important role” in the UK clearance. He said the process allowed authorities “to immediately begin to review the files, review the data, come back with questions that we can answer immediately. And this greatly accelerates the process of in-depth evaluation of the data that we have provided.”
When can I get vaccinated in the UK?
The UK will start rolling out the vaccine next week, according to Health Secretary Matt Hancock. But emergency clearance is only the first stage in that process – doses will be assigned according to clinical priority.
Each recipient of the Pfizer / Biontech vaccine will need two doses.
An independent panel of experts, the Joint Committee on Vaccination and Immunization (JCVI), recommended that residents and staff of nursing homes get vaccinated first.
The panel recommends that people then get vaccinated according to age, starting with people over the age of 80 and with front-line healthcare workers.
So age will continue to be the deciding factor, with older adults vaccinated into those over 50.
JCVI experts have also reported that UK National Health Service (NHS) workers and those considered clinically extremely vulnerable to coronavirus it should be prioritized in the initial phase of vaccination.
Those considered vulnerable include cancer patients, those taking medications that weaken the immune system, and those with severe lung disease, severe kidney disease, and other health conditions.
Hancock said Wednesday that the timing of how many people are vaccinated “will depend on how quickly (the doses) can be made.”
“We haven’t calculated the numbers before Christmas,” he said. “But what we do know is that we can start next week with that first load, and several million will come during December. The NHS will reach out to people when it’s their turn.”
“I strongly urge you to make yourself known, because obviously being vaccinated is good for you,” he added. “It is approved as clinically safe by the regulator and it is also good for your community to help bring this virus finally under control once and for all.”
There are logistical challenges facing the launch, as the vaccine must be kept at temperatures of minus 70 degrees Celsius (minus 94 Fahrenheit) before use. Once thawed, Pfizer says the vaccine can be stored for up to five days at 2-8 degrees Celsius in refrigeration units that are commonly available in hospitals.
Speaking to Sky News on Tuesday, Hancock said there would be “a combination of three modes of delivery.”
The vaccine will go to hospitals first, 50 of which are waiting to receive doses. This will be followed by vaccination centers, which Hancock says are now being established, ahead of a “community rollout” that will include doctor’s offices and pharmacists.
How does the mRNA vaccine work?
The Pfizer / BioNTech vaccine uses a new approach to making vaccines that uses messenger RNA or mRNA.
MRNA is a single strand of the genetic code that cells can “read” and use to make a protein.
For this vaccine, the mRNA instructs the cells of the body to produce a particular part of the spike protein of the virus. The immune system sees it, recognizes it as foreign, and is prepared to attack when an actual infection occurs.
What are the side effects of the Pfizer vaccine?
An independent group has been watching the trial results and the side effects of the vaccine.
Pfizer and BioNTech say there were no serious side effects during the large-scale trials.
To date, the Data Monitoring Committee for the study “has not reported any serious safety issues related to the vaccine,” the companies said.
The only notable side effect was fatigue in some trial participants.
“The only requested Grade 3 (severe) adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.7% after dose 2,” the companies said.
Paul Offit, a professor of pediatrics at Children’s Hospital of Philadelphia, told CNN on Wednesday that some side effects are normal for vaccines.
“That means your immune response is working for you. You should feel good about that,” he said, while discussing the side effects.
He added that if people experience side effects with the first dose, then there should be “no difficulty getting that second injection again, knowing that you are now in a much better position to fight this terrible virus.”
Is it safe to take more than one vaccine?
Other drug companies, Moderna and AstraZeneca, also have promising vaccine candidates.
The UK government says studies are underway to determine whether the AstraZeneca and Pfizer / BioNTech vaccines can be given interchangeably in the two doses, as “both … are effective.
“There is no evidence of the interchangeability of the different COVID-19 vaccines although studies are underway. Therefore, every effort should be made to determine which vaccine the individual received and complete with the same vaccine, “says the UK government, although exceptions are allowed.
The guide adds that for people who have received a dose and “attend vaccination in a place where the same vaccine is not available, or where the first product received is unknown, it is reasonable to offer a single dose of the product available locally.” “although he adds that this option is preferred if the person” is likely to be at immediate high risk or considered unlikely to attend again. “
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