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Sunday, October 17, 2021
Home Categories Biotech BREAKING: Pfizer about to seek FDA's emergency approval!

BREAKING: Pfizer about to seek FDA’s emergency approval!

The race for the first effective Covid-19 vaccine is highly anticipated by the public worldwide. After having struggled with the pandemic for almost a year, the population is ready for a break. The same goes for the economy. After the hopeful news reported by Moderna earlier this week, Pfizer comes with an optimistic announcement today.

Almost 95% Effective With The Older And More Vulnerable

After the first data set showing the complete data, Pfizer announced that the vaccine does not have any substantial side effects and it’s close to 95% effective. A very crucial part is that the vaccine remains that level of effectiveness with people older than 65. Apart from being the most vulnerable group amidst the pandemic, the elders may not react to certain types of vaccines. Thus, Pfizer’s results are very promising. The only visible side effects were headaches and fatigue that were observed among approximately 2% of the people.

Data-Based On More Than 40 000 Participants

Their data is based on more than 41 000 patients that were given the vaccine in two doses. The sample of volunteers who received the jab was diverse, with different ethnic backgrounds and quite even sex and age distribution. 41% of all volunteers were older than 56 years old. Having said that, although Pfizer achieved satisfactory results, that does not mean the trials are over. For a few more years, intensive research will take place, in order to be able to fully comprehend the efficiency of the vaccine.

Pfizer To Seek Emergency Approval From FDA

The company already declared it will seek emergency approval from the Food and Drug Administration (FDA). The company said the approval will be applied for “within days”. They have also revealed that they will simultaneously be submitted to regulatory bodies across the world.

Reactions To The Successful Results Of Phase 3 Trials

Albert Bourla, the CEO of Pfizer, has said “The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” in an official statement. He has since also commented on the news via his official Twitter account. Bourla has thanked everybody who is “working day and night to help us make this a reality”

 

Albert Bourla’s official Twitter announcement.

 

Pfizer’s early analysis that was made public last week claimed a 90% effectiveness. That number was slightly lower than the 94,5% reported by Moderna on Monday. The current effectiveness numbers of Moderna and Pfizer are practically equal. Having said that, Pfizer will be forced to release more detailed data in order to receive peer review.

Reaction Of The Regulators

Both Pfizer and Moderna are likely bound to become recognized for hyper-speed when creating the vaccine. Creating a vaccine is usually a process that takes several years. In this case, we may be expecting effective protection against Covid-19 within 1,5 years since the beginning of the pandemic. However, since the beginning of the year, The list of companies may be longer as more than 10 companies around the world are in Phase 3 testing. More than 50 have shown promising results in earlier stages.

Reactions Of The Market

After Pfizer’s revelation, the financial market reacted enthusiastically, with S&P 500 moving up. Although the information on FDA approval and even more interestingly, the distribution of the vaccine are still to be confirmed, markets already celebrate. S&P 500 did not have such a strong beginning of the month since 1997.

Reaction Of The UK Government

The UK has already preordered 40 million doses of the vaccine that should be enough to protect 20 million older and more vulnerable citizens. The first doses are believed to arrive in the UK at the end of the year. The other countries around the globe are likely to follow the UK soon. Pfizer is projected to produce almost 1,5 billion vaccines by the end of 2021. Right now, we are awaiting the FDA’s approval. Subsequently, an effective plan regarding the distribution of the vaccine that has to be stored at negative 74 degrees celsius will have to be implemented.

If you find any mistakes or inaccuracies in this article, please don’t hesitate to contact us via email at info@regtechglobal.com

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