As COVID-19 cases still rise, many are questioning how far along the vaccine has come or when distribution will be available. While many vaccines have made it to phase three of the vaccination approval process, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, has said that a vaccine will not be ready for distribution until January.
Currently, there are 170 teams of researchers racing to develop a vaccine. Of that number, 154 of these teams are in the pre-clinical phase. Thirty-six are in phase one, 16 in phase two, and 11 in phase three.
All but one of these vaccines in stage three require a two-dose process.
The purpose of the phases that vaccines go through are to ensure safety of the vaccine.
Before vaccines enter the clinical phases, they must go through pre-clinical testing. This is where researchers give the vaccine to animals to see what responses occur.
The first phase involves clinical trials of the vaccines in a small scale. Phase two allows an expansion in these trials. Phase three is another expansion of the vaccine trials. Lastly is phase four where the vaccine is approved for use.
Usually, these four phases take years or even decades to assure that a vaccine is safe, but due to the spread of COVID-19, Operation Warp Speed has been implemented to speed the time on a vaccine.
With Operation Warp Speed, scientists expect and hope that they will be able to develop a vaccine within 12 to 18 months.
Moderna, a front-runner in the COVID-19 vaccine race, is already prepping for the launch of its potential coronavirus vaccine. Moderna has already taken $1.1 billion in deposits from the governments awaiting to launch the vaccine.
This company has had continued discussions with the World Health Organization and already has supply agreements in many regions of the world including North America.
Moderna’s vaccine has been made with the help of the National Institute of Health. Their vaccine uses messenger RNA, in hopes that it will provoke the immune system to fight off COVID-19.
Moderna has already had 26,650 participants receive the second round of the two-dose vaccine. Within these participants, 37% were from diverse communities and 42% were at high risk of severe disease.
One of the 11 vaccines in phase three of the vaccination process, Pfizer has said that it plans to ask the Food and Drug Administration for emergency-use authorization in November, once testing is complete.
Pfizer is already in its final-stage trial with nearly 44,000 participants of the vaccine worldwide. Nearly 36,000 have received the second shot of the vaccine.
While Pfizer has not reached their safety milestone yet, they expect to soon.
Another company in the race for a vaccine, Johnson and Johnson, plan to begin testing a COVID-19 vaccine in children 12 to 18. In hopes of testing youth, Johnson and Johnson hopes they can help move the vaccine faster.
Currently Johnson and Johnson are in discussion with regulators and partners on including pediatric populations in these trials.
Although the U.S. Food and Drug Administration has said it is important for vaccines to be tested in children, many doctors have raised their concerns. Many worrying that the vaccine itself could trigger a condition called Multisystem Inflammatory Syndrome in children.
In the vaccine race, Johnson and Johnson have already started testing 60,000 volunteers in phase three of the process to get the vaccine approved. While testing occurred in late September, Johnson and Johnson had to suspend testing due to a serious medical event in one participant.
Johnson and Johnson are currently able to continue the study again as of the week of Oct. 18.
Even though many companies have made major progressions in vaccines, the World Health Organization has said it does not expect widespread vaccination until the middle of next year. This is due to ensuring the safety of the vaccine approved.
Fauci has also stated that a vaccine will not be ready for distribution until sometime next year. He has also stated that around December, we will start to see companies with enough events and recommend a company to move the vaccine forward. He also explained how this process will move it forward to applying for emergency use authorization from the Food and Drug Administration.
With the vaccines moving forward in their clinical trials at a rapid pace, a vaccine is expected in early January.