Why did the UK allow the first coronavirus vaccination?

Britain is among the countries hardest hit by the pandemic, Europe has the highest number of deaths and its government has been heavily criticized for tackling the crisis.

But now both the European Union and the United States have jumped with this announcement.

Why was the UK the first?

The vaccine was emergency-approved in the UK by its independent regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), which played a crucial role in the process.

MHRA began an ongoing review of Pfizer and BioNTech data in October, and each data package had to be reviewed as it became available. This allowed regulators to examine the data in detail before submitting the final permit application.

According to the MHRA, an ongoing review “can be used to conduct an evaluation of a promising drug or vaccine in a public health emergency in the shortest possible time.”

This approach helped speed up the permitting process, and a formal review of all necessary information began in the UK on 23 November, leading to Wednesday’s announcement.
UK to be first country to approve Pfizer Covid-19 vaccine, first shots released next week

“I think the advantage is that the MHRA has carried out a rolling review, which means that Pfizer has collected data on vaccine production […] The MHRA has been able to keep up with this, “David Salisbury, of Chatham House’s global health program, told CNN.” This allowed the MHRA to stay alert and up to date. “

A similar rolling review approach is used by the European Medicines Agency (EMA). The EMA began the review process of Pfizer’s data on October 6, and BioNTech and Pfizer filed a request to complete the review process on December 1. The EMA has announced that it will complete its review by 29 December at the latest.

EU Member States may not distribute Covid-19 vaccine until it has been approved by the EMA and signed by the European Commission in accordance with EMA rules.

The European Commission (EC) would then need a few days to prepare legal papers and discuss the authorization decision with the Member States, according to an EC spokesman.

“The fact that the MHRA was able to accomplish this quickly is reflected in the pace at which Pfizer contacted 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 of its vaccine candidate. The application was filed on November 20th.

The FDA’s Advisory Committee on Vaccines and Related Biological Products, a panel of independent experts, should meet on Dec. 10 to discuss the use of Pfizer.

According to a U.S. Operation Warp Speed ​​document obtained by CNN on Tuesday, the first shipments of Pfizer’s coronavirus vaccine will be delivered on Dec. 15 if the vaccine is granted an emergency permit.

Özlem Türeci, BioNTech’s chief medical officer, said the company was waiting for responses from the EMA and FDA by mid-December.

Türec said on Wednesday that the ongoing review process had “played an important role” in the UK permit. According to him, the process allowed the authorities to “immediately start reviewing the dossiers, review the data, return with questions that we can answer immediately. This will significantly speed up the process of thoroughly evaluating the data we provide.”

When can I get a vaccine in the UK?

Health Minister Matt Hancock said the UK would start introducing the vaccine next week. But emergency authorization is only the first stage in this process – doses are allocated according to clinical priority.

Each recipient of the Pfizer / Biontech vaccine will need two doses.

An independent panel of experts, the Joint Vaccination and Vaccination Committee (JCVI), recommended that the residents and staff of the shelter be vaccinated first.

The board then recommends that people be vaccinated according to their age, starting with those over the age of 80, as well as health workers working at the front.

Age will continue to be a deciding factor, with older adults vaccinated up to those over 50 years of age.

JCVI experts also advise that in the initial phase of vaccination, priority should be given to UK National Health Service (NHS) staff and those considered clinically highly vulnerable to the coronavirus.

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 on Wednesday how many people “will determine the date of the vaccination and how quickly.” [doses] can be manufactured. ”

“We didn’t put a number on the numbers before Christmas,” he said. “But we know we can start with this first load next week and millions will arrive by December. The NHS will be in touch with people when it’s their turn.”

“I urge you to take action because obviously vaccination is good for you,” he added. “The regulator has described it as clinically safe and it will also benefit its community if it has permanent control of the virus.”

The introduction will face logistical challenges as the vaccine must be kept at a temperature of minus -70 degrees Celsius (minus -94 Fahrenheit) before use. After thawing, Pfizer says the vaccine can be stored for up to five days at 2 ° C to 8 ° C in refrigeration units commonly available in hospitals.

In a Sky News speech on Tuesday, Hancock said “there will be a combination of three delivery methods.”

The vaccine is first sent to hospitals – 50 of which are on standby to receive doses. This is followed by vaccination centers, which Hancock is said to have just set up, before a “community introduction” involving doctors’ offices and pharmacists.

How does the mRNA vaccine work?

The Pfizer / BioNTech vaccine uses a new approach to produce vaccines that use messenger RNA or mRNA.

MRNA is the only strand of the genetic code that cells can “read” and use to make a protein.

For this vaccination, the mRNA instructs the cells in the body to make a certain piece of the viral spike protein. The immune system sees it, recognizes it as a stranger, and is ready to attack when an actual infection occurs.

What are the side effects of Pfizer?

An independent group monitored the test results and side effects of the vaccine.

Pfizer and BioNTech said there were no serious side effects in the large-scale trials.

To date, the study’s data monitoring committee “did not report any serious safety concerns about the vaccine,” the companies said.

The only notable side effect was fatigue in some experimental participants.

“The only grade 3 (severe) side effect with a frequency of 2% or more after the first or second dose was 3.7% fatigue after the 2nd dose,” the companies said.

Paul Offit, a pediatrician professor at the Philadelphia Children’s Hospital, told CNN on Wednesday that some of the side effects from the vaccinations are normal.

“That means the immune response works for you. You have to feel good about it,” he said as he discussed the side effects.

He added that if people experience side effects from the first dose, there can be no “difficulty getting back to the second shot, knowing that you are now in a much better position to fight this terrible virus”.

Is it safe to give more than one vaccine?

Other pharmaceutical companies, Moderna and AstraZeneca, also have promising vaccine candidates.

According to the UK government, studies are underway to determine if AstraZeneca and Pfizer / BioNTech vaccines are interchangeable in the two doses, as “both … are based on viral spike protein”, but it is not yet clear how effective this is.

“There is no evidence of interchangeability between different COVID-19 vaccines, although studies are ongoing. Therefore, every effort should be made to determine which vaccine an individual has received and supplement with the same vaccine,” says the UK government, although exceptions are allowed.

The guide adds that for people who have had a single dose and are “taking vaccines where the same vaccine is not available or where the first product obtained is unknown, it is reasonable to offer a single dose locally,” although he adds that this option is preferred if the individual is “likely to be at immediate high risk or unlikely to participate again.”

CNN’s Amy Cassidy, James Frater and Lindsay Isaac contributed to the report.