It is no secret that the world is now racing to be the first to develop a safe and effective Vaccine for coronavirus. Though every Vaccine indeed requires years of testing and research, the Covid Vaccine is seemingly at its results stage. There are now 44 Covid Vaccines at the clinical trial stage on humans, while over 91 preclinical vaccines are now under active animal investigations.
The road ahead concerning the Covid Vaccine is uncertain despite the first research beginning in January this year. The scientist started by deciphering the SARS-CoV-2 genome. Not all the 44 Vaccine under the trial will succeed. Some will fail, while others may produce unclear results. The article will deliberate on the status of vaccines that are in the trial stage in humans.
The Vaccine Testing Process
There steps that every Vaccine must follow before it reaches the approval stage.
Preclinical Testing of Covid Vaccines
Preclinical testing is the first stage where scientists test a new vaccine on cells. They then give it animals such as mice or even monkeys to see if it will produce an immune response. Ninety-one preclinical Covid Vaccines are now available in active development. The world is now hopeful that the preclinical vaccines will bring the best results.
Phase 1: Safety Trials
Scientists will then administer the Vaccine to a small population. The phase 1 safety trials intend to test for safety and dosage to check if it will stimulate the immune system.
Phase 2: Expanded Trials
In phase 2 expanded trial, the scientist will give the Vaccine to a more significant population where they split it into groups. Here the research targets children and elders. The intention here is to see if the Vaccine will yield different results. The scientist is very keen on the effects that the vaccines will cause to stimulate an immune response.
Phase 3: Efficacy Trials
The third stage now targets thousands of people where the scientist administers the drug to many people, and they will then wait to see how the Vaccine will affect them. They will then make a comparison to the way it involved the volunteers who received a placebo. The trials can give a roadmap if the coronavirus vaccine can protect against Covid.
Notably, from the FDA report in June, they affirm that the trials test was to establish if Covid Vaccine will protect at least 50% of the vaccinated people. Phase 3 is also extensive and capable of revealing the rare side effects that may miss in other trials.
Early Approval/Limited Approval
Recently in the news, China and Russia approved their vaccines. They did not wait to see the impact of phase 3 on their test. Notably, a process like this may pose a significant risk to the population, according to experts.
The regulators in every phase will then have to review the trial results and decide whether they will approve or not. Notably, a vaccine will receive emergency authorization before getting formal approval when there is a pandemic. After approval, researchers will continue monitoring people who accept to ensure their safety.
Sometimes, it becomes necessary to accelerate vaccine development. Here the researchers combine the steps. It now evident that some coronavirus vaccines are in both phases 1 and 2 trials.
Covid Vaccines Updates
It will worth checking the updates on Covid 19 Vaccine to affirm if it is giving the best results. There are many updates from various research institutes concerning the development of the Vaccine.
The company is the forefront runner in attempting to develop the Coronavirus Vaccine. Moderna is developing vaccines basin on the messenger RNA to produce viral proteins in the body. The vaccines are not yet available in the market.
It started working on the vaccines in January, and the government has been very supportive. From the report, the Company received a bankrolling of over $1 billion in partnership with the national institute of health. Among the first impressive results is the realization that the Vaccine can protect monkeys from Corona Virus.
The company then had to place the first trials in March to humans. The results were encouraging. The Vaccine is now progressing to the phase 3 trials where the Company started it on July 27th.
They are now focusing on their final trial, where they are enrolling 30000 healthy people in over 89 sites in the US. The government is tirelessly supporting them, and they now have $1.5 billion, which they will exchange with 100 million doses if the Vaccine will yield the best results, according to the report on August 11th. The Canadian government later agrees to take 20 million doses in September.
The Journey has not been very smooth for the company. They lost a patent dispute over the vaccine technology, where the Company later states that they were not sure to make the patent’s inventions. Recently, on September 17th, Moderna shared a protocol that guides in determining the safety and effectiveness of their Covid Vaccines. The Company needs to wait until the end of the year 2020 to allow a significant number of volunteers to become sick of Covid 19 and then see how many will have been vaccinated.
The German BioNTech Company
The BioNTech Company is also working towards developing a Covid 19Vaccine. They entered a collaboration with the Pfizer Company in New York and the Chinese drugmaker Fosun Pharma to try to establish an MRNA, which will be administered in two doses.
The Company launched phase 1 and 2 trials in May on the two versions of Vaccines. From the test results, it was evident that the volunteers were producing antibodies against the SARS-COV-2 and the T-Cells, which was responding to the virus.
Another version, BNT162B2, was characterized by fewer side-effects such as fever and fatigue. They then have to begin phase 2 and phase 3. They had to launch steps 2 and 3 on July 27th with over 30000 volunteers in the United States and other countries such as Argentina, Brazil, and Germany.
The results were awe-inspiring. On administration of the first dose, most volunteers were experiencing minor side effects. The two Pfizer and BioNTech companies later made it public that they will have to seek the expansion of participants in the US to 43000 participants.
Later on the same month, the Trump administration awarded a $1.9 billion contract for 100 million doses, which the Company should deliver before December. They also had an option to acquire 500 million more quantities. Japan later reached a deal for 120 million doses while the European Union purchased 200 million doses.
Pfizer’s CEO gave an optimistic view about the Covid 19 vaccines, and he said that by October 2020, they would affirm if the Vaccine is working. If they approve the Vaccine, they expect to manufacture over 1.3 billion doses of their Vaccine by the end of 2021.
In July, the Indian Vaccine maker initiated a DNA-based vaccine delivered through a skin patch. They launched the phase 2 trial on August 6th.
From the reports from March, it is evident that the Trump administration had unsuccessfully tried to move Germany based research to the United States. They later launched the mRNA vaccine after a elapse of 3 months, and the first injections were given to volunteers in Panama and Peru. Phase 3 trial to start soon before the end of 2020. CureVac Company expects to make 100 million doses by the end of 2020, and they hope to get approval by 2021. They already have the upper hand after collaborating with Elon Musk Tesla Company for micro-factories worldwide, which will speed the manufacture of billions of doses.
Imperial College London
Researchers in this Company is now developing a self-amplifying RNA vaccine, which will significantly boost the production of the viral proteins, which will stimulate the immune system. The Company started phase 1 and 2 trials on June 15th, having partnered with Morningside Ventures. They intend to manufacture and distribute the Vaccine through a brad company called VacEquity Global Health. They plan to get the final results on the Covid Vaccine’s effectiveness by the end of the year.
Anges is one of the best Japanese biotechnology company that started phase 1 trials of a DNA based Vaccine on June 30Th. They develop the Vaccine in partnership with Osaka University and Takara Bio. The initial phase 1 results will be announced in November, and the phase 3 trial shall begin before the end of the year.
Arcturus Therapeutics and Duke-NUS Medical School
One of the best California-based companies is now working on developing mRNA vaccines. The vaccines have a self-replicating ability, which therefore stimulates a more excellent production of viral proteins.
From the test results that they obtain after administering it to animals, it is evident that the Vaccine can protect against infection. The Company then launched phase 1 and 2 trials at Singapore hospital.
Inovio is also not left behind. They are now developing the Covid Vaccines, which can be delivered through the skin. They use a handheld device to provide the electric pulse through the skin. Vaccines are now available in clinical trials for several disorders.
The Company announced the interim data from the phase 1 trial on Covid 19, and happily, there were no severe side effects with an immune response from 34 out of 36 volunteers. On September 28th, the Company made it public that the vaccines are now on a partial clinical hold as per the FDA due to the delivery device’s issues.
Genexine is a Korean company that started working on a DNA base Covid Vaccine in June. They are anticipating to proceed with the second phase during the fall.
The Chinese researchers at the academy of military medical sciences, Suzhou Abogen Biosciences, and WallVax Biotechnology hope to star there country’s safety trials on an RNA based vaccine. Notably, the Vaccine is already tested with monkeys, and they showed protective results.
Thailand’s Chulalongkorn University
Thailand University is also working on developing several potential vaccines for the Covid 19. They now have the ChulaCov19 Vaccine, which is mRNA based. They registered the phase 1 trial results on September 29th.
France based pharmaceutical Company is working on an mRNA vaccine now while in partnership with Translate Bio. The results they have so far are awe-inspiring since their Covid Vaccine produces healthy antibodies response in monkeys. They will soon start their phase 1 trial before the end of December.
How Does The COVID-19 Vaccine FDA Approval Timeline Work?
Let’s take a look at the COVID 19 Vaccine approval timeline at FDA. Many vaccines are now in their last stages. People all over the world are waiting for the first Vaccine that will get approval.
Many front runners are now undergoing numerous human trials. The approval is still facing uncertainties because no one has already executed confidence and announce when the Vaccine will be ready. The Covid 19 Vaccine timeline is still dim, though many companies speculate it to be the end of this year.
When the vaccines are ready, that is when the FDA will then evaluate them. The Company submits the vaccines to the FDA when it is sure that they have completed all the processes. According to the FDA, the phase 3 trial should show at least 50 percent protection. When we take a look at this argument, it is evident that most companies are now edging to their last stage.
The Covid 19 Vaccine will then be evaluated under an emergency use authorization, where the researchers will be keen on safety and side effects. According to the strat news report, it is worth noting that every data review process can take a whole year. In instances where there is an emergency, it takes 3 to 6 months.
From the arguments mentioned above, it is evident that the Vaccine will not be ready by the end of this year. The FDA will be collecting data during the emergency authorization period, where the FDA will be looking for any respiratory-related cases and any potential side effects.
The Agency then takes the data to the third party advisory committee before approving any drug. Their rules are strict, and therefore, everyone should expect a delay in releasing the Covid 19 vaccine.
To conclude, the Cov 19 vaccine is what everyone is waiting for. Indeed, people are now observing the safety guidelines that only reduces the number of cases. It will be a significant milestone when the last news shall be announced on the first Covid 19 Vaccine. Let us hope for the best.