Pfizer to Submit Clinical Trial Data For Regulatory Preview

Pfizer to Submit Clinical Trial Data For Regulatory Preview
April 5, 2021

Video Source: CBS News on YouTube

 

Biopharma company Pfizer Inc (NYSE: PFE) has claimed 100% efficacy for its COVID-19 vaccine in a trial involving youngsters in the age group of between 12 and 15, implying that the outcome of the trial could pave the way for administering the vaccine in middle school students before the reopening of school this fall. On Friday, the stock closed at $36.30, almost flat from the previous close.

The New York-based Pfizer’s CEO Albert Bourla stated that the company intends to table the latest data on the COVID-19 vaccine, which is produced in collaboration with Germany based drug manufacturer BioNTech, to the US-based Food and Drug Administration (FDA) and other market regulators very soon so that children in the age above group can be vaccinated before the forthcoming school year.

Bourla, in a media release, stated that Pfizer is also interested in quickly expanding the administration of the COVID-19 vaccine to adolescents. Furthermore, he expressed his happiness about the upbeat clinical trial data related to youngsters in 12 and 15.

The trial involved 2,260 volunteers in the US. In the Placebo group, 18 affirmed COVID-19 infections were recorded, but there were no confirmed infections in the age group administered with the vaccine. That implies an efficacy of 100%. The company noted that the dose was well-tolerated and side-effects, if any, were similar to those recorded in adults.

Pfizer also stated that the vaccine created a strong antibody response in children, better than the one seen in a previous trial involving 16 to 25-year older adults.

Public health officials and experts on infectious diseases have opined that vaccinating children is an absolute necessity for ending the pandemic. Health experts have pointed out that the US public may not attain herd immunity (people having antibodies against COVID-19 until children get vaccinated.

Children comprise roughly 20% of the US population, as per government data. Furthermore, 70% to 85% of the country’s population needs to be vaccinated to achieve herd immunity. Notably, some adults refuse to get vaccinated.

Dr. Scott Gottlieb, an ex-commissioner of the FDA and a Pfizer board member, stated that he anticipates the US regulatory agency to take around a month to study the latest data. In case the FDA process goes smoothly, as per Gottlieb, the COVID-19 vaccine could be administered to children in the age group of 12-15 by fall.

Isaac Bogoch, an expert in infectious diseases and a member of numerous data and safety tracking boards, called the outcome “wonderful news,” stating it as a significant initiative in safeguarding an increasing number of people against the COVID-19 infections and making schools secure for kids.

Bogoch said, “We’re talking about improving the safety of youth activity like youth sports and youth art and youth extracurricular activities.”  

The COVID-19 vaccine developed by Pfizer-BioNTech has already received approval for administration in people aged 16 years and older. Clinical trials on kids aged below 16yrs are yet to be completed.

Dr. Anthony Fauci, the chief medical advisor of White House, informed a House committee last month that the country could start administering vaccines on older kids by this fall. In contrast, kindergarten kids may be issued with the vaccine by the beginning of next year.

Pfizer started its COVID-19 vaccine trial on kids in 12 to 15 in October 2020. A week before, the company revealed that it had created a clinical trial of its vaccine on healthy 6-month to 11-year-old kids.

During the trial’s initial stage, Pfizer will administer various dosage levels to arrive at the cordial level for kids in the three age groups, namely six months to 2 years, 2-5yrs, and 5-11yrs.

First, kids will start receiving a 10-microgram dose of the COVID-19 vaccine before a step-by-step increase to higher doses. Volunteers will also be provided with the choice of starting with 3-microgram doses.

Bogoch opined that it would not be easy to forecast the trial outcome as the vaccine could work differently in kids and adolescents. However, he expressed his optimism about the development of the trial.

Pfizer has also announced that it intends to apply for an amendment to the prevailing emergency use authorization issued by the FDA to encompass kids in the age group of 12 to 15. The company further stated that all volunteers would be monitored for two years after the second dose.

The solid clinical trial data is expected to keep the stock bullish in the days ahead.

The price chart indicates strong support for the stock at 33. The next resistance is anticipated only near 40. Additionally, the stock is trading above its 50-day moving average, while the stochastics indicator is ascending. Therefore, we are expecting the stock to remain on an uptrend in the near term.

pfe - technical analysis - 5 April 2021

Disclaimer: Any financial trading analysis offered here is our opinion and is not intended as advice or direction for investors. We cannot guarantee the success of any trades made as a consequence of this article, and we encourage traders to incorporate a strong money management strategy to limit losses when they enter the markets. Please use this article as part of your own research before formulating strategies prior to trading.

Andrew Wright

Prior to founding tradersasset.com in 2014, Andrew worked as a proprietary trader, then as a market maker. As a market maker, he traded options in over 100 stocks, he then began trading currency pairs in 2013. Andrew still actively trades both, and prides himself on educating and informing traders on the benefits of both Binary Options and Forex.


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