Coronavirus Vaccines Update 2/26/2021
As of Friday February 26, 2021, there are two vaccines approved by the Food and Drug Administration (F.D.A) for use in the United States, with three others in the final stage (Phase 3) of clinical trials. The two approved vaccines are the Pfizer-BioNTech and Moderna COVID-19 vaccines. Vaccines that are nearing the end of their clinical trials are AstraZeneca, Janssens (Johnson & Johnson), Novavax’s COVID-19 vaccines. All vaccines, both approved and in testing, aside from the J&J vaccine, are two-dose vaccines, with follow-up vaccinations occurring anywhere from 3-5 weeks post initial inoculation.
Currently, at least one dose of either approved COVID vaccine has been administered to almost 14% of the United States population, according to data submitted by the Centers for Disease Control (C.D.C). The speed in which Americans have been able to receive a vaccination has been steadily increasing over the last three months. Now, with three vaccines nearing the end of their clinical trials, millions of people are waiting for their turn to roll up their sleeve and get vaccinated.
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As COVID-19 shows no signs of slowing, the race to fast-track a coronavirus vaccine is intensifying all over the world. In the US, scientists are working furiously on Operation Warp Speed, trying to produce a safe and effective vaccine by the end of the year.
Is that timeline realistic? Some say no, but no one can say for sure. Read on to learn about the vaccine development process, when the experts hope to see one, and why a firm date is hard to predict.
Coronavirus Vaccine Development Cycle
Vaccines usually take years to create, particularly for a novel (new) virus like SARS-CoV-2 (the virus that causes COVID-19). Fortunately, researchers have a head start on this one because of research done on other coronavirus outbreaks in recent history — SARS in 2003 and MERS in 2012. That research is helping to fast-track a COVID-19 vaccine.
The first step in developing a new vaccine is to learn the genetic code of the virus. That work was done for SARS-CoV-2 in January, according to the New York Times Coronavirus Vaccine Tracker. From there, scientists develop and then test the vaccines.
Researchers use one of several mechanisms when creating their vaccines. Some are based on inactivated virus, others on RNA or DNA coding, for example. Any of these may turn out to be safe and effective.
Here are the phases that an experimental vaccine must go through in the development process:
- Preclinical testing: Testing on animals.
- Phase 1 safety trials: Testing on a small number of people.
- Phase 2 expanded trials: Testing on hundreds of people.
- Phase 3 efficacy trials: Testing on thousands of people in a controlled trial with placebo groups.
- Approval: Each country reviews the trial results (in the US, the regulator is the FDA) to determine if the vaccine worked (if the immune system produced antibodies), and if it’s safe and effective. In a pandemic when a vaccine is urgently needed, the FDA may approve it for emergency use before formal approval is given. The FDA will continue to follow vaccinated people to monitor safety and efficacy.
Researchers may combine phases (such as phase 2/3) to speed up the development process.
Coronavirus Vaccine Development Status
As of August 20, 2020, here is the rundown on how many vaccines are in the pipeline and where they are in the development stage:
The Phase 3 Candidates
As of August 21, there are eight vaccines in phase 3 clinical trials — one in the US, one in Australia, one in Germany, one in England. The remaining four are in China.
Approved for Limited Use
Two vaccines have been approved for early use, one by Sinovac Biotech in China and one from a Russian research institute. Both of these were approved before phase 3 trials were done. Some researchers, such as Dr. Anthony Fauci, have expressed reservations about the safety and efficacy of vaccines that have not undergone phase 3 trials.
“remarkably swift for a process launched only months ago,”
Coronavirus Vaccine Candidates In the United States
In the US, one manufacturer—Moderna—is in phase 3 trials. Moderna has proven that their vaccine has great potential, and it was able to provoke an immune response in monkeys.
If it passes phase 3 successfully, it could be approved by the end of the year, but it won’t go into actual use until mid-2021. This is “remarkably swift for a process launched only months ago,” according to the Baltimore Sun. President Trump has already ordered 100 million doses.
Novavax also has a strong candidate with encouraging results. Interestingly, the platform they use is different from others. They are using spike proteins to trigger an immune response.
Like Moderna, they have proven that their vaccine works in monkeys, with better results than Moderna’s, according to Akiko Iwasaki, an immunologist at Yale University. Novavax is just beginning phase 3 trials, but because different vaccine types can have different production times, it’s possible that they could have the first doses by early 2021.
“It’s important that all who need the vaccine can get it.”
Ethics Concerns
When a vaccine is approved, there will be widespread differences of opinion on who should get it first. It will take time to produce enough to vaccinate the global population.
Countries funding the research feel they should have first access, while others feel that those at highest risk, regardless of country or financial involvement, should get the first vaccine doses.
There are also racial implications, Dr. Susan Bailey, president of the American Medical Association, said in a news conference. She stressed that Blacks and Hispanics are about three times more likely to get the virus as Caucasians and twice as likely to die. “It’s important that all who need the vaccine can get it.”
Good News for Chronic Pain Sufferers?
To that end, an ethics framework published by Johns Hopkins suggests a two-tier system for distributing the first vaccines fairly. Those at higher risk of severe illness are included in tier one. The immunocompromisation that often comes with chronic pain may put some sufferers in that high-risk group.
“At the same time, we will not, we cannot go back to the way things were.”
Will a Vaccine Mean the Pandemic Is Over?
Unfortunately, that’s not likely to be the case, according to World Health Organization (WHO) director Tedros Ghebreyesus at a recent news conference. “Every person and family has a responsibility to know the level of COVID-19 transmission locally and to understand what they can do to protect themselves and others,” he said.
“At the same time, we will not, we cannot go back to the way things were.”
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