Pfizer COVID-19 Vaccine Expands Trials

September 17th, 2020   admin   Health and Wellness Tags: , ,

Pharmaceutical company Pfizer Inc., working with German company BioNTech, has made promising progress regarding the development of a COVID-19 vaccine.  This news comes shortly after the previously disheartening announcement that a frontrunning contender developed by AstraZeneca and Oxford University was pausing clinical trials in order to investigate whether a severe illness in a patient was linked to Oxford’s vaccine.  AstraZeneca has recently been given the green light to begin work again.

But Pfizer is one company that may outstrip AstraZeneca when it comes to reaching approval for a vaccine.  The company is expanding its clinical trial from 30,000 to 44,000 people.  They are using this to expand the demographics they’re testing to include a wider diversity of people, such as younger teenagers and people with diseases such as HIV and some types of hepatitis. 

This past Tuesday, Pfizer reported that participants seem to primarily be experiencing mild-to-moderate side effects from the injection, such as fatigue and headache.  Among the participants, there have also been some who developed fevers. However, the double-blind nature of the study means that Pfizer does not know who has received a vaccine or a placebo.

The Pfizer vaccine, called BNT162, must be at least 50% effective in order to be federally approved.  BNT162 works by using ‘messenger RNA.’  This messenger RNA, also called mRNA, is designed to get a person’s cells to produce an antigen associated with COVID-19, which will train the immune system to recognize it and produce antibodies against it.

Business magnate Bill Gates has expressed that he does not believe the vaccine will be available by the end of October the way that some, including President Trump, seem to hope; however, though he has dismissed this ambitious timeline as unlikely, Gates admits that the company with the greatest likelihood of finishing the vaccine at such an accelerated pace is likely Pfizer. 

Speaking to CNBC, Gates said, “The only vaccine that if everything went perfectly, might seek the emergency use license by the end of October, would be Pfizer.”

However, of a possible vaccine, Gates does say that by the time December 2020 or January 2021 arrives, “the chances are that at least two or three” will be seeking approval. 

Despite political and public pressure, and amid concerns from the general population that a vaccine will be politicized or rushed, multiple pharmaceutical companies, Pfizer among them, pledged to maintain the ethical and scientific integrity of their work, saying that they would not seek approval for a vaccine unless it proved safe and effective in trials first.

CEO of Pfizer, Albert Bourla, said that Pfizer was deliberately revealing more information about their COVID-19 vaccine than their other work because, “Transparency is a must, particularly given this situation and the politicization of the vaccine.”

Regardless of when the vaccine becomes available, Dr. Scott Gottlieb, who is on Pfizer’s board of directors and who formerly worked for the FDA, cautions that their vaccine will not likely achieve broad-based immunity in 2020.

As the vaccine has gone through development, it has been checked regularly by an independent Data Safety Commission for any health concerns and safety issues.  With their expanded trials, Pfizer hopes that they will have more data on the safety and effectivity of the vaccine ready for review by next month, the results of which will likely play a role in determining the rest of the timeline for the development and rollout of the vaccine.

By Leslie Williams

Sources:

USA Today, Pfizer reports ‘potential’ with COVID-19 candidate vaccine after expanding trial to 44,000 people : https://www.usatoday.com/story/news/health/2020/09/15/covid-19-vaccine-pfizer-positive-update/5808960002/

CBSN, Pfizer CEO says company will know if vaccine works by end of October: https://www.cbsnews.com/news/covid-vaccine-effectiveness-october-pfizer/

CNBC, Bill Gates doesn’t expect a virus vaccine before year-end — but he says one drugmaker has the best chance: https://www.cnbc.com/2020/09/15/bill-gates-doesnt-expect-a-coronavirus-vaccine-before-year-end.html

Businesswire, Biopharma Leaders Unite to Stand with Science: https://www.businesswire.com/news/home/20200908005282/en/

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