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News Article

COVID-19 Vaccine: Too Good to Be True?

By Miriam Bello | Wed, 09/09/2020 - 16:57

Leading the race toward a COVID-19 cure was the alliance between AstraZeneca and Oxford University, which is currently going through Phase III of clinical trials on thousands of patients around the world. Unfortunately, it was yesterday that news about an adverse reaction on this vaccine started to circulate.

According to the press release posted by AstraZeneca today, this controlled trials on the AstraZeneca Oxford COVID-19 vaccine “AZD1222” had to be temporary paused “to review the safety data of a single event related to an unexplained illness that occurred in the UK Phase III trial.” The release details that this is a routine action to take after there is an inexplicable illness related to the trials to ensure the safety of all participants and the high standards of the trails. The company highlights that it will take quick action to avoid delaying the trials and maintain their integrity.

The announcement first came through STAT and on that report it is explained that there is still no clear relation between the reaction and the AstraZeneca Oxford vaccine as the person presenting the anomaly suffered from transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often caused by viral infections.

On the other hand, there is the Russian vaccine development called “Sputnik V” which has been very controversial. This development is the first ever approved vaccine against SARS-CoV-2. It is based on two adenovirus vectors and it works “quite effectively, helps to develop immunity and has gone through all the necessary tests,” according to Russian President Vladimir Putin. While already approved, this vaccine has not even started Phase III of the trials and had no public results of previous trials. Up to date, results of Phase I/II are available in The Lancet detailing that the vaccine “induced a strong immune response in all 76 participants.” However, FDA and EMA discussed that data on immune response alone would not generally be an adequate basis for approving a vaccine. The Lancet cites Peter Openshaw, professor of experimental medicine at Imperial College London, saying that “immune response might not be directly proportional to the degree of protection; you can only find this out in large-scale trials.”

Aside from the many speculations on the vaccine, Mexico has already established an agreement with the Russian government to obtain 32 million doses of “Sputnik V” through the Mexican pharmaceutical company Landsteiner Scientific. The vaccine is expected to arrive in Mexico in November as long as it complies with the regulatory measures. This development is currently being tested on 40,000 people in Russia as part of Phase III trials.

Which developments are next in line?

-Moderna Therapeutics started its Phase III clinical trials on July 27.

-BioNTech and Pfizer is also on Phase III of clinical trials since July 27 and expecting results by the end of October.

-Sinovac, a Chinese company, is going through Phase II trials since June 24 and released a preliminary result saying that its vaccine induced neutralizing antibodies in “above 90 percent” of participants.

-Sanofi and GlaxoSmithKline’s development is on Phase I/II since September 3 on 400 volunteers and expects results by December. Mexico will be part of Phase III trials of such development.

-Johnson & Johnson is on preclinical trials and Mexico is expected to participate on Phase III of the trials.

-CanSino Biologics, Inovio Pharmaceuticals and Novavax also have advanced developments on Phase I/II of trials for its COVID-19 vaccine.

Miriam Bello Miriam Bello Senior Journalist and Industry Analyst