Last week there was further excitement when Moderna announced promising results in COVID-19 vaccine testing. The question now is - what the next step? The FDA has stated, "We are in no hurry."
Here is a summary of an exciting week in the world of science.
Last week was marked Pfizer's announcement of an extensive success in the third phase of the clinical trials in the vaccine development. At the beginning of the same week, we received an additional dramatic announcement from Moderna. Like its predecessor, Moderna announced preliminary findings from the third phase of clinical trials, showing an impressive 95% efficacy level.
Although these are preliminary findings, and things may still change, the two companies are working hard to find results. In fact, they suggest injecting RNA molecules (mRNAs), a new vaccine method, which shows promising results.
Keep in mind; the existing information is incomplete. We do not know the vaccine's side effects. It is not clear
- 1. If the vaccine offers immunity to the virus for a long-term period.
- 2 . Is not known if the vaccine works on at-risk populations such as the elderly and diabetics.
However, there is already hope that we will be able to overcome the COVID-19 and move forward.
Next step: FDA approval
Last week, Pfizer dropped another media bomb, announcing that it had completed collecting the data it needed to apply to the U.S. Food and Drug Administration (FDA) for emergency approval of the vaccine. The updated data analysis presented updated the vaccine's efficacy rate to about 95%, similar to Moderna. The small change may fall within the statistical error range.
Still, it is certainly encouraging to know that the results did not change drastically, even after adding 76 patients to the data. According to Pfizer, no serious side effects were observed; patients report dizziness and headaches only. Another encouraging fact is that the vaccine's effectiveness is no less significant in vaccinated people over the age of 65.
The trial is not over yet, and it will take a long time to detect rare side effects and learn how long the immune memory stays. However, due to the global pandemic’s high mortality rates, they will try to obtain emergency clearance and distribute hundreds of millions of doses.
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Vaccine Distribution- will they succussed
The Pfizer vaccine uses a sensitive nucleus that must be kept in 70 degrees Celsius below zero along the entire distribution chain. That is a significant logistical nightmare. The company has already announced a pilot distribution test in several states hoping to find logistical solutions. The Moderna vaccine remains stable even at 20 degrees below zero.
Meanwhile, the FDA is making sure to cool the enthusiasm a bit. In an interview with Business Insider, the director of the Center for Biologics Evaluation and Research (CBER) at the FDA, Peter Marks, said they were "not in a hurry." He added that it is necessary to "restore public confidence in vaccines" and that the process be transparent. The vaccination and approval procedure of the vaccine appears to take several weeks.
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Who will be next in line?
The eyes are now on the next two companies: Johnson & Johnson and AstraZeneca. Both are in the advanced stages of the third stage. Both have developed vaccines based on a type of virus that is not harmful to humans. The virus is supposed to enter the vaccinated people and incorporate itself into the DNA in order to trigger one of the virus's proteins. In most vaccines, it is the same protein.
The immune system is supposed to recognize the protein, produce antibodies against it, and develop an immune memory. AstraZeneca is expected to publish interim results soon. Johnson & Johnson has announced the opening of another third-phase trial, this time with a vaccine given in just one dose instead of two. Preliminary results are expected in the coming months.
The Indian company, Bharat, joined the race. Bharat is expected to begin the third phase of clinical trials, which is based on a killed Corona virus. The plan is to test 26,000 volunteers in India.
The Russian government continues to issue statements about the high efficacy within their vaccine. The Russian reports are received with skepticism by the scientific community. The Russian test includes 20 patients, well below the threshold provided by Western health authorities.
Will you be vaccinated?
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