epa08853381 A handout photo made available by Pfizer shows manufacturing operations related to the Covid vaccine at the Pfizer bioNtek in Puurs, Belgium, issued 30 November 2020. EPA/PFIZER / HANDOUT HANDOUT EDITORIAL USE ONLY/NO SALES

Approval of Covid-19 Vaccine in Europe Applied by Pfizer, BioNTech

Pfizer is a giant US pharmaceutical company in London that has been developing a coronavirus vaccine. The covid-19 pandemic has changed the lives of so many people. Ever since it first began at the start of 2020, this pandemic managed to change the way we live. Unfortunately, a lot of people felt the disadvantage of this awful situation. That is why a lot of people are hoping for something that can help end the pandemic.

A vaccine is one of the things that can help in this kind of situation. A vaccine can help people when it comes to granting immunity to the virus. That way, even if a person gets in contact with the virus, they will not get sick. Even if they get sick, the symptoms will not be as bad as if the person is not vaccinated. That is why a vaccine can be helpful in this situation.

However, the coronavirus vaccine is still being developed by so many companies now. One of the companies that have managed to make the vaccine is Pfizer. This US pharmaceutical giant worked with its partner, which is BioNTech. BioNTech itself is a German biotechnology company that develops therapies for a variety of diseases. Fortunately, the development of the coronavirus vaccine by these companies has been quite promising.

Pfizer and BioNTech have applied for the marketing authorization of their very own coronavirus vaccine. They said that they have applied for the approval of the vaccine to the European Medicines Agency. If the vaccine ends up being approved, it will be available for use in Europe in December 2020. BioNTech made a statement that makes this information pretty clear. This can be very good news, considering how helpful a vaccine can be at a time like this.

The European Medicines Agency is a European agency that is responsible for evaluating and supervising medicinal products. These medicinal products include vaccines. If a company wants to distribute any medicinal product, it needs to ask for approval from the European Medicines Agency.

In the case of this coronavirus vaccine, authorization is needed for the vaccine to be distributed. This kind of authorization is usually granted to medicines that will help fulfill patients’ medical needs. Normally, the European Medicines Agency needs a lot of comprehensive data to grant authorization of a medicine. However, because the coronavirus has become a pandemic, the authorization can be granted with less data than what is normally required.

So, let’s talk more about how it works and why the authorization of such medicine is different. The European Medicines Agency works in the interest of public health. This means that this agency approves medicines based on the advantages that the public will get from those medicines. If the benefit of immediate distribution of the medicine outweighs the risk of not having comprehensive data, then a conditional marketing authorization can be granted to the medicine. In this case, a conditional marketing authorization can be granted to the coronavirus vaccine that has been developed by Pfizer and BioNTech.

The basis of such authorization is, of course, the public health interest. However, the pharmaceutical company that developed the product needs to remember one important thing. The company or applicant needs to be able to provide the European Medicines Agency with comprehensive clinical data somewhere in the future. That way, the required data need for the medicine will eventually be met.

Dr. Albert Bourla, the Chairman and CEO of Pfizer, has made quite a promising statement. He said that the approval application is a key milestone for this pharmaceutical company. Why? Well, simply because this giant pharmaceutical has made a promise to do anything, they can to address the coronavirus crisis. The company cares deeply about the health needs of the public. Therefore, this vaccine becomes an effort that they do to help the world in the middle of this crisis. Dr. Bourla also acknowledges the patients that have been waiting for the vaccine. Fortunately, this company is ready to ship doses of the covid-19 vaccine as soon as it is authorized. That way, the public will be able to truly feel the immediate benefit of the covid-19 vaccine that has been successfully developed by Pfizer and BioNTech.

To sum it all up, Pfizer is a giant US pharmaceutical that has been working with BioNTech to develop a coronavirus vaccine. This vaccine will be able to help a lot of people all over the world. However, these companies are still waiting for the authorization of conditional marketing by the European Medicines Agency. Once the authorization is granted, the vaccine can be marketed immediately in December 2020.