According to a recent article in Fiercepharma, vaccines based on new technology are being developed by AstraZeneca, Moderna, and Johnson & Johnson. The trials will be funded and conducted by the federal government, according to comments by one of their lead vaccine researchers.
A word of caution was offered by a former FDA chief who questioned the use of these very new technologies. In addition, researchers at Oxford University, who are developing a vaccine with AstraZeneca, suggested that some of these vaccines may stop COVID-19 but may not prevent its transmission.
The National Institute of Health will begin Moderna’s phase III vaccine trials in July. AstraZeneca and Johnson & Johnson trials will follow in August and September. These three vaccines are finalists in the government’s Operation Warp Speed.
Meanwhile, seven other vaccines are being developed in other parts of the world. A total of 123 vaccines are being tested in labs but have not yet entered the phase 1 stage to be tested on humans.
Changing Timelines
After announcing its first human testing scheduled for September, Johnson & Johnson reversed course and decided to accelerate efforts for its phase 1/2a trial in July of this year.
The third company AstraZeneca, along with Moderna, is currently in Phase II testing. A spokesperson for Moderna confirmed its contract with the government and forthcoming Phase III test.
However, AstraZeneca’s representative acknowledged a late-stage test without confirming the date of the testing. The company entered a government contract that committed AstraZeneca to deliver millions of COVID-19 vaccines.
Pfizer also added its name to the list with an announcement that it could begin a phase III trial next month. Dr. Anthony Fauci, NIAID chief, commented that we may see the development of more than one successful vaccines.
Better to be Safe
The magic number is thirty thousand. Each of the studies will enroll approximately thirty thousand people. Researchers will only begin the studies once it is confirmed that the vaccines are safe and can protect people against the infection.
A group of scientists from the NIAID will publish the details of Moderna’s initial study. In the meantime, Moderna announced that the antibodies used in the vaccination of a small group of people neutralized the COVID-19 virus in the lab.
Moderna’s phase II study will enroll a total of six hundred people who are in good health. Researchers will follow these subjects for safety and additional data for one-year after being injected.
The phase II study will eventually include essential workers or nursing home residents who may have been exposed to COVID-19.
Moderna was one of five developers selected to participate in the government’s Operation Warp Speed program. The goal, in addition to speeding development of a COVID-19 vaccine, is to eventually vaccinate three hundred million people with its mRNA-1273 vaccine beginning in early 2021. Moderna plans to produce five hundred million to one billion doses of the vaccine beginning next year.
About Vaccines
Vaccines build immunity by working with the body’s defense system. Vaccines contain substances that mimic infections. Some are dead or weakened bacteria or viruses. Many people believe that the symptoms they experience after vaccination are from the actual virus. It is true that vaccinations may cause side effects but they will not cause you to become ill from the virus you are being vaccinated against.
Some vaccines will protect a person for life and others may require booster shots. Your immune system will “remember” that particular virus if you are exposed to it again.
Before the pandemic, developing a vaccine would take ten to fifteen years. In the last few years, the FDA has created certain designations to expedite its review and approval of new drugs. Yet the speed with which the COVID-19 vaccines are being developed is unprecedented.
After being tested in cells, then in mouse models, drugs usually undergo three phases of testing in humans, which normally takes several years.
The third phase of the clinical trial series normally takes one to four years. Twenty-five to thirty percent of new drugs that undergo phase 3 trials successfully move on to await the FDA’s approval. If the drug is approved it moves on to finally licensing.
The field is crowded with contestants. It is possible that more than one vaccine may be approved. Due to the enormous number of vaccines needed throughout the world, that would not only be beneficial but also a relief.
