Fri. Mar 31st, 2023
coronavirus vaccine

On Wednesday, the UK became the first Western nation to approve a Covid-19. Vaccine marking a crucial moment in the global fight against Coronavirus.

British authorities have given emergency permission for the Pfizer/BioNTech. Vaccine and the first doses are expected to be carried out early next week.

Britain, with the highest death toll in Europe, was one of the countries hardest. Hit by the pandemic, and its government has been heavily criticized for its handling of the crisis.

But this announcement has now leapfrogged both the European Union and the United States.

Here’s what you need to know about how the covid 19 vaccines was approved:

The vaccine was granted emergency authorization in the United Kingdom by the Medicines.
And Healthcare Products Regulatory Agency (MHRA), its independent regulator, which played a key role in the process.

As of October, the MHRA started a rolling review of Pfizer and BioNTech data, with each. “Package” of data reviewed as soon as it was made available.
This enabled regulators to review the data in detail before a final application for authorization was submitted.

A rolling review, according to the MHRA, “can be used to complete the assessment. Of a promising medicine or vaccine during a public health emergency in the shortest time possible.”

This approach helped boost the authorization process and on 23 November a formal review of all the necessary. Information Began in the UK, leading to the announcement on Wednesday.

“I think the advantage is that the MHRA has been undertaking a rolling review. Which means that as Pfizer accumulated data on how they manufactured the vaccine… MHRA could keep pace with that,” David Salisbury, an associate fellow in Chatham House’s Global Health Programme, told CNN. “That has allowed the MHRA to be nimble and keep pace.”

The European Medicines Agency uses a similar rolling evaluation strategy to (EMA). On October 6, the EMA started its review process of the Pfizer data and on. December 1, BioNTech and Pfizer applied to complete the review process. The EMA has said that its analysis will be completed by 29 December at the latest.

Unless approved by the EMA and signed off by the European Commission in compliance. With the EMA regulations, EU Member States cannot administer the Covid-19 vaccine.

According to an EC spokesman, the European Commission (EC) will then require a few days. To draft a legal document and negotiate the authorization decision with the Member States.

“The fact that the MHRA has been able to do this quickly will be a reflection at the pace. At which Pfizer was interacting with them,” Salisbury added.

Pfizer already applied to the US Food and Drug Administration (FDA) for an emergency authorization. For its vaccine candidate, in addition to the UK and the EU. 

The FDA’s Advisory Committee on Vaccines and Associated Biological Products. A body of independent experts, is scheduled to meet to discuss Pfizer’s proposal on December 10.

The first shipments of Pfizer’s coronavirus vaccine will be shipped on December 15, if the vaccine is given emergency permission. 

Chief Medical Officer Özlem Türeci of BioNTech said the organization expects EMA and FDA responses by mid-December.

Türeci said that the rolling review process played “an important role” in the UK’s authorization. She said the process allowed authorities to “start right away to go through the dossiers. Review the data, and come back with questions which we can respond to immediately. And this massively accelerates the process of assessing in-depth the data we have provided.”


According to Health Secretary Matt Hancock, the UK will begin rolling out the vaccine next week. Emergency permission, however, is just the first step of this procedure — doses will be distributed according to clinical priority.

Each Pfizer/Biontech vaccine recipient would require two doses.

The Joint Committee on Vaccination and Immunization (JCVI), an independent body of experts. Has recommended that residents of nursing homes and staff are vaccinated first.

The panel advises that citizens, beginning with people older than 80 as well as frontline health. Staff, can then be vaccinated according to age.

Height will then appear to be the decisive factor, with the vaccination. Of elderly people down to those older than 50.

JCVI specialists also recommended that in the initial process of vaccination, staff in the UK’s National Health Service. (NHS) and those deemed clinically highly susceptible to coronavirus should be prioritized.

Patients with cancer, people that are taking medications that suppress the immune system. And others that have serious lung disease, extreme kidney disease, and other health problems are considered vulnerable.

Hancock said Wednesday that the timing of how many people can be vaccinated. “Will be determined by how rapidly (doses) can be manufactured.”

“We haven’t put a figure on the numbers before Christmas,” he said. “But what we do know is we can get started next week. With that first load, and several million will be coming throughout December. People will be contacted by the NHS when it’s their turn.”

“I urge you very strongly to come forward because being vaccinated is good for you,” he added. “It’s approved as clinically safe by the regulator and it’s good for your community. As well to help get this virus finally under control once and for all.”

The launch faces technical difficulties as the vaccine has to be kept before use at temperatures of minus 70 degree. Celsius (minus 94 Fahrenheit). Once defrosted, Pfizer claims the vaccine can be kept in refrigeration. Systems that are widely available in hospitals for up to five days at 2 to 8 degrees Celsius.

Speaking to Sky News on Tuesday, Hancock said there would be “a combination of three modes of delivery.”

The vaccine will first go to hospitals — 50 of which are on standby to receive doses. This will be followed by vaccination centers, which Hancock said were being set up. Now, before a “community rollout” including doctors’ offices and pharmacists.


A modern approach to producing vaccines using messenger RNA, or mRNA, is used in the Pfizer/BioNTech vaccine.

mRNA is a single genetic code strand that can be “read” by cells and used to produce a protein.

The mRNA instructs cells in the body to produce a clear piece of the virus’s spike protein for this vaccine. The immune system sees it, identifies it as foreign, and can strike when there is a true infection.


An independent group has been holding an eye on the results of the trial and the vaccine’s side effects.

Pfizer and BioNTech state that during large-scale experiments, there were no serious side effects.

To date, the Data Monitoring Committee for the study “has not reported any serious. Safety concerns related to the vaccine,” the companies said.

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

“The only Grade 3 (severe) solicited adverse event greater than or equal to 2% in frequency. After the firs or the second dose was fatigue at 3.7% following dose 2,” the companies said.

Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia, 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 side effects.

He added that should people experience side effects from the first dose. Then there shouldn’t be “any difficulty coming back for that second shot, knowing. That you’re now in a much better position to fight off this awful virus.”

Is it safe to take more than one vaccine?

Other drugmakers, 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 across the two doses. Since “both … are based on the spike protein of the virus,” but so far it’s unclear whether this is effective.

“There is no evidence as to 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 to complete. With the same vaccine,” the UK government says, though exceptions are permitted

The guidance adds that for people who have had one dose and “attend for vaccination. At a site where the same vaccine is not available. Where the first product received is unknown. It is reasonable to offer a single dose of the locally available product. “Though it adds that this option is preferred. If the individual “is likely to be at immediate high risk or is considered unlikely to attend again.”

By gnews