American biotechnology company Moderna’s COVID-19 vaccine is entering the final stages of testing. They say they’re getting closer to finishing production. Recently published results found in the New England Journal of Medicine from earlier stages are promising.
COVID vaccine testing
There are 23 COVID-19 vaccines in human trials right now. There are a handful of vaccines entering the final Phase. Breaking up vaccine testing into phases is standard procedure. Phase 1 consists of a few dozen volunteers. Soon after, phase 2 doesn’t add many more participants but they expand upon variables. Phase 3 is a large-scale test with thousands of volunteers. This process tests safety and effectiveness.
Testing for M-RNA 1273, Moderna’s vaccine, began on March 16. Initially, there were 45 volunteers, all aged from 18 to 55. Soon after on May 18, Moderna announced that they produced antibodies similar to those who have recovered from the virus. Antibodies are key molecules in the bloodstream which fight the virus.
Moderna applied to for Phase 2 testing approval. The Food and Drug Administration responded by granting Fast Track Designation. Fast Track is the Food and Drug Administration’s attempt to help speed up vaccine production. The urgent need for a coronavirus vaccine called for this program.
Phase 2 trials were conducted by the U.S. National Institute of Allergy and Infectious Diseases. It consisted of 600 healthy volunteers. Half of them were between 18 and 55, the remainder of them were over 55. The study is continuing to follow them. The results are not published yet. As of right now there haven’t been any serious health risks.
Finally, the third and last phase of vaccine testing will have about 30,000 participants. There are other companies performing tests on this scale. Some of them like Pfizer, Johnson & Johnson, and Oxford University will have vaccines being tested on around 30,000 individuals. The tests will take place across the United States. The first injection centers will be in Baltimore, Rockville and D.C. Tests will begin on July 27 and from there will expand testing. 87 locations across the U.S. will administer the vaccine. Sign-ups are now live. This speedy production is record-setting speed for vaccine development.
Moderna’s COVID vaccine
Moderna’s vaccine is based on mRNA technology. This type of vaccine has never been put on the market before. Traditional vaccines are DNA based. Moderna is going for record-setting vaccine production and RNA makes that possible. It has many advantages over DNA for speed and efficiency. It allows Moderna to produce more materials, test samples sooner, distribute on a mass level.
The vaccine is generally safe and tolerable. Dr. Tal Zaks, Moderna’s chief medical officer states that, “At a high level, M-RNA 1273 was generally safe and well tolerated”.
Patients must take two doses, 28 days apart from each other. Different dosages are tested. The low dosage is 25 micro-grams. Medium is 100 micro-grams. Finally, the high dosage is 250 micrograms. Testing went swimmingly for Phase 1 and 2, although four incidents occurred. One of them being Ian Hayden’s story, for instance.
Ian Hayden’s Severe Reaction
In Phase 1 testing, four individuals got a bit more than they bargained for. Side effects were typical for most, and Phase 2 participants are experiencing the same ones. Those being common fatigue, headache, chills, fever, and also pain at the injection site. Luckily, these would only last for about a day.
Ian Hayden experienced the most severe reaction out of any COVID vaccine tests. The 29 year old from Seattle fainted at home and had a fever of 101 degrees.
The team conducting the study met him at the hospital he was taken to. He was ensured attention and proper care. In addition, the study is covering any and all medical costs for patients who experience severe reactions and hospitalizations. There is also a 24-hour hotline.
Hayden received the highest dosage of the vaccine, which is 250 micro-grams. This dosage was not used in tests after this incident. Phase 3 will test people with 25 and 100 micro-grams.
The worldwide need for COVID vaccines
There is fierce competition among medical companies to be the first one with a COVID vaccine. Investors, countries, and other companies are betting on certain companies to be first or one of the firsts.
Trump’s Operation Warp Speed is funding Moderna and providing resources. The FDA Fast Track designation is also helping. Other frontrunning vaccines consist of a Chinese vaccine and Oxford University + AstraZeneca’s vaccine. They will be entering the final stage of testing soon.
Dr. Anthony Fauci, America’s leading doctor on the pandemic, tells the Associated Press, “No matter how you slice this, this is good news”. And he’s right. The world will need many vaccines, so from many different companies. One company can’t do it all. Above all, experts all claim that many vaccines are important to stop the virus.
Moderna’s CEO Stephane Bancel states that there is a high probability that the company’s coronavirus vaccine could reach the distribution stage in 2021. Hopefully Phase 3 trials will go well.