COVID-19 Vaccines and Self-Testing

Zarina Sotero, Staff Writer |

Currently no vaccines have been developed and distributed for COVID-19. However, scientists and medical professionals are hard at work to develop a vaccine for the virus that is currently spreading all over the world. Moderna Inc., a biotech firm, is among one of the many companies working on developing a vaccine.

Moderna has been working to develop a vaccine since January 2020 after Chinese authorities shared the genetic sequence of coronavirus. Moderna’s infectious disease research team worked with the U.S. National Institutes of Health (NIH) to finalize the sequence of a vaccine called mRNA-1273. It took 25 days, from sequence selection to manufacturing, for the first clinical batch to be completed. The vaccine is now being used in a study of a group of 45 volunteers. These volunteers are healthy and have not been infected with SARS-CoV-2, the virus that causes COVID-19.

On March 16, 2020, the NIH announced that the first participant in its Phase One study was dosed with mRNA-1273. Phase One of this study is evaluating the safety and immunogenicity of the different dose levels of the vaccine. The vaccine will be administered on a two-dose vaccination schedule, given 28 days apart. The participants of the study will be monitored 12 months after receiving the second vaccine. Moderna reported the vaccine will not be commercially available for at least another year. However, it is possible a vaccine could be available in the Fall of 2020 to some people, possibly including healthcare professionals. Dr. Stephen Hoge, president of Moderna, stated that if the vaccine proves to be safe and successful, the company is preparing for an “incredible demand to scale up the vaccine very, very quickly.” Hoge says that the company has “already started to do work to scale up to producing millions of doses.”

While a vaccine  is still being developed, startup companies have begun to distribute self-testing and at-home coronavirus kits. With the rising panic surrounding the coronavirus pandemic, more people are eager to get tested. Unfortunately, there is a shortage of testing kits in the U.S., and the small amount of testing kits available are being reserved for high-risk groups, such as the elderly. Startups such as Carbon Health and Nurx have reacted to this shortage by creating their own testing kits for people to use themselves. Carbon Health and Nurx both said they were preparing to offer thousands of kits in the coming weeks and could cost up to $200.

However, there have been many concerns about these at-home tests. One of the most important concerns regarding at home tests the tests is the accuracy of the results. With COVID-19 tests, timing is crucial. Someone may take a test too early and then later end up with the virus but might still believe they are unaffected. With the possibility of false negatives comes high risks of these people unknowingly infecting others through in-person contact.

Another problem that arises with at-home tests is the risk of people taking the test inaccurately. For an accurate test, a person must swab deep in the back of their nose or throat where the virus is most active. A swab that is done too shallow could make someone believe that they don’t have COVID-19 and, again, unknowingly infect others.

In addition to these concerns, FDA COVID-19 testing guidelines specifically forbid at-home testing. The FDA updated its Emergency Use Authorization guidelines on March 21, which now clarify that at-home sample collections are not supported by the FDA. Following the update, startups distributing these tests must now immediately discontinue their testing programs and destroy any samples they have already received. People must go to an authorized clinical or  drive-through testing site and will still have to meet the Centers for Disease Control and Prevention’s (CDC’s) screening requirements in order to get tested.

The COVID-19 pandemic has caused worldwide panic. Please follow the CDC’s tips to slow and prevent the spread of the virus. Practice social distancing, wash your hands often with soap and water for at least 20 seconds, avoid touching your face, stay home if you are feeling ill and cover your cough or sneeze with a tissue.

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