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COVID-19 Vaccines: Clinical Trials to Public Distribution

Since mid-March, international powers such as the United States, Europe, and China, have competed to create COVID-19 vaccines as infection, and mortality rates, have increased throughout the world. Biotechnology and pharmaceutical enterprises across the globe have been leading this process, and those at the forefront include Pfizer, BioNTech, and Moderna. Companies such as AstraZeneca, Johnson & Johnson, Sinovac, Novavax, and Sinopharm have made contributions as well.

Clinical Trials

Clinical trials for various vaccines started in the months following their development. Some trial processes and results have been briefly described here:

BNT162b2

Pharmaceutical company Pfizer initiated a Phase 1/2 trial for their two mRNA vaccines in May, with German biotechnology company BioNTech as a partner. One of these versions, known as tozinameran, was discovered to have fewer side effects. This feature propelled it into the next stage of vaccine development and distribution, eventually revealing an efficacy of 95 percent with two doses administered three weeks apart.

mRNA-1273

Clinical trials for a mRNA vaccine developed by Moderna, a Massachusetts-based biotechnology company, began in mid-March of last year. A Phase 3 trial ultimately resulted in a 94.1 percent efficacy for two doses of the vaccine, which were administered with an interval period of four weeks.

ChAdOx1 nCoV-19 

In the spring, British-Swedish pharmaceutical company AstraZeneca, in partnership with Oxford University, started clinical trials in Britain to test their adenovirus-based vaccine. In a November 23rd press release, AstraZeneca revealed that data from their trials found an efficacy of 90 percent when a half dose of vaccine was followed by a full dose at least a month later. Another dosing regimen, including two full doses, had only a 62 percent efficacy.

JNJ-78436735 

A division of Johnson & Johnson called Janssen Pharmaceutica, which is based in Belgium, is currently working with Beth Israel Deaconess Medical Center to test their vaccine. Unlike other vaccine trials, this one involves a total of one dose per participant. January is when the results of their clinical trial are expected to be announced.

CoronaVac

Sinovac, a Chinese biopharmaceutical company, developed an inactivated vaccine and began clinical trials in June. Phase 3 trials have taken place in several countries, including Brazil, Indonesia, Turkey, and China. Though the details of their research still remain unknown, the government of Turkey reported that the Sinovac vaccine had an efficacy of 91.25 percent in their trial.

NVX-CoV2373

In May, clinical trials began for a protein-based vaccine created by Novavax, a Maryland-based vaccine development company. The vaccine was shown to produce a high level of antibodies in early trials, and has since entered Phase 3 trials in the United Kingdom and United States. The United Kingdom’s Phase 3 trial results are expected in early 2021.

BBIBP-CorV

An inactivated vaccine developed by the Beijing Institute of Biological Products was put into Phase 1/2 clinical trials by Sinopharm, a Chinese pharmaceutical company, by June of 2020. It has now been approved in China, Bahrain, and the United Arab Emirates. Despite releasing no comprehensive data, the United Arab Emirates claims the vaccine had an 86 percent efficacy, while Sinopharm has reported that the vaccine had a 79.34 percent efficacy.

Along with the aforementioned vaccines, China and Russia have been developing various other variations. There is little to no information on the vaccines that have been produced, and even administered, in Russia and China, though we do know that there are approximately four of them.  

Emergency Use Authorizations in the U.S.

The month of December marked the issuing of emergency use authorizations by the U.S. Food and Drug Administration (FDA). On December 11th, after making its debut in the United Kingdom, the Pfizer-BioNTech vaccine was the first to receive an emergency use authorization. The Moderna vaccine was granted emergency use authorization a mere week later. No other vaccines have received this authorization from the FDA.

The two vaccines have since been administered throughout the United States, and millions of additional doses are expected to be received in the following year. This is partially the result of a recent deal between the Trump administration and Pfizer that guarantees the U.S. an additional 100 million doses of COVID-19 vaccine by July 31st, 2021.

U.S. Vaccine Distribution 

Vaccine doses that currently reside in the U.S. are likely to be distributed based on risk of virus contraction. This would be consistent with guidelines released by the Centers of Disease Control and Prevention (CDC), which have recommended that healthcare workers and residents of long-term care facilities be the first to receive the COVID-19 vaccine. (It is important to note that states are not obligated to follow the CDC’s guidelines. That choice is in the hands of each state’s governor.)

This first phase of the distribution process described in the CDC’s recommendations, also known as Phase 1, is divided into three parts: Phase 1a, Phase 1b, and Phase 1c. While Phase 1a involves the people previously specified, 1b expands access to frontline essential workers and those aged 75 years or older. Finally, Phase 1c includes other essential workers, people from ages 65 to 74, and people from ages 16 to 64 with increased risk due to medical conditions.

The general public should expect to begin receiving vaccines in the spring of 2021, following the inoculations of people most at risk. However, with difficulties in vaccine distribution, such as unique storage requirements, large-scale transportation efforts, and lack of public trust in vaccines, there is a level of uncertainty as to how the process will play out.

Distribution of vaccines to youth is also a faraway idea, with clinical trials for children and adolescents 12 years or older now progressing from the early stages. Infectious disease expert Dr. Anthony Fauci explained on CNN that he and researchers are “looking at January … to start some trials in children” with “children who are a bit older.” The ages of youth participants in vaccine trials will also vary depending on which vaccine is being tested, as the Pfizer-BioNTech vaccine was given authorization for those aged 16 years or older and Moderna’s vaccine was given authorization for those aged 18 years or older. 

What Should Be Done Now?

For now, everyone will have to continue to stay at home as much as possible. When the need to leave and complete essential tasks arises, wear a face covering to help reduce the spread of the virus and protect others.  

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