Posted on : May 21, 2020 by Clinic One on COVID-19
Moderna’s COVID – 19 candidate vaccine (mRNA Vaccine or mRNA-1273) against the Novel Corona Virus (SARS-CoV-2) generated positive results on its Phase I clinical trial, according to the interim data presented by the company on a press release on Monday, 18 May 2020.
According to the study
- All the participants of the study produced antibodies against the Novel Corona Virus.
- The Candidate Vaccine mRNA -1273 was overall safe and well endured by the human body.
- Phase III of the clinical trial is expected to start by July 2020.
Moderna Inc, a biotechnology company based in Cambridge, Massachusetts, pioneered this study in association with NIAID (National Institute of Allergy and Infectious Diseases).
Details of Phase I Study of Moderna’s COVID -19 Vaccine (mRNA-1273)
The primary objective of Phase I clinical trial, for the development of any medication or vaccine, typically includes the assessment of the safety and reactogenicity of the vaccine on the human body.
But, surprisingly when the medical officers at Moderna checked the presence of antibodies neutralizing against the virus, they found that all the participants had developed it.
There were an estimated 105 healthy volunteers above the age of 18 years enrolled in the Moderna’s mRNA -1273 phase I trial, where the antibodies level was measured in 8 of them.
The volunteers received 2 doses of mRNA Vaccine 28 days apart, the third dose to be followed after 12 months (day 394) of the second dose.
Only 1 participant developed erythema (redness of the skin) around the injected area upon receiving 25 µg – 100 µg dose of the vaccine. 3 other participants developed a notable fever and flu-like symptoms when given a dose of 250 µg during the trial. The reactions were temporary.
Moderna also stated that the participants receiving 25µg – 100 µg of the mRNA vaccine produced more antibodies than the people that recovered from the COVID – 19 diseases against the virus.
The vaccine also seemed to exhibit a dose-response. The participant who received 100 µg produced more antibodies than the person receiving a 25 µg dose of the vaccine.
This is at the speed of light! No other time had a vaccine been developed so quickly. So, while these findings are encouraging, we are only at the beginning. We are not there yet. So, let’s be calm and let science take its time to do its right thing.–
Dr. Carlos del Rio, Co-Principal Investigator, Emory’s Vaccine, and Treatment Eval. Unit.
FDA’s Fast Track Program for the Development of Vaccine
Normally, the development of a vaccine takes years for research, awaiting result approvals and securing funding sources. The current record for creating an entirely new vaccine is at least 4 years.
But for a life-threatening situation like this, the FDA (Food and Drug Administration) has a Fast Track Program that facilitates the accelerated development of new vaccines and drugs.
The FDA has approved Fast Track Designation for Moderna’s mRNA vaccine against Novel Corona Virus on 6 May 2020, authorizing it to proceed to the Phase II of the clinical trial.
Infectious disease Experts reckons that even with this program, the estimated arrival of Moderna’s COVID – 19 Vaccine can take from 12 to 18 months.
Since the development of mRNA Vaccine started in early January this year, the officials expect the delivery of the vaccine to the public in January 2021.
Moderna’s mRNA-1273 is the 2nd vaccine to enter Phase II of clinical trials, the 1st being the Recombinant Novel Coronavirus (2019-nCOV) Vaccine (Adenovirus Vector) by CanSino Biological Inc led by Beijing Institute of Biotechnology of Beijing, China.
If everything goes well in the future studies, the vaccine could be available to the general public from January.Dr. Tal Zaks, Moderna’s chief medical officer, Source: CNN.
According to WHO’s Draft landscape of COVID-19 candidate vaccines, the mRNA vaccine is one of the 8 candidate vaccines under the clinical trial stage against the Novel Corona Virus. Likewise, there are still 110 candidate vaccines in the pre-clinical evaluation period.
What Happens in the Phase II Study of Moderna’s COVID -19 Vaccine?
According to Moderna’s Press Release on 12 May 2020, Phase II of the study will determine the final dose of the vaccine to be used in Phase III of the trial.
Two different doses of the mRNA vaccine of 50 μg and 250μg will be used in two different groups of an estimated 600 healthy participants of age group (300 from 18 – 55 years & 300 from 55 < years).
The medical officers will then study the safety, tolerability, and efficacy of the given doses during the 1st and 2nd schedule of vaccination. The third dose of the vaccine will be followed at day 391 (12 months after the vaccination).
Moderna expects the beginning of Phase III as soon as the trial period of Phase II completes, starting in July 2020. Phase III will enroll about 30,000 volunteers across the United States for the clinical trial to adhere to the efficacy of the vaccine.
Even at this pace, if Moderna’s mRNA COVID – 19 Vaccine successfully completes its Phase III trial in January, there are still concerns regarding the manufacturing capacity of the company in large volumes.
Once the vaccine gets approved, the company still needs a substantial amount of time to mass-produce billions of doses necessary to meet the current need and demand of the vaccine across the world.
Dr. Carlos del Rio mentioned that even if the things go on as they should, the availability of the COVID – 19 vaccines across the world still might stretch out to next July.
We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.–
Stéphane Bancel, Chief Executive Officer at Moderna.
Moderna Inc (18 May 2020), Moderna announced positive interim Phase 1 data for mRNA-1273., Press Release
Moderna Inc (12 May 2020), Moderna received FDA Fast Track designation for mRNA-1273., Press Release
WHO (15 May 2020), Draft landscape of COVID-19 candidate vaccines
National Institute of Allergy and Infectious Diseases (NIAID), Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19)
(17 March 2020), A phase I clinical trial for recombinant novel coronavirus (2019-COV) vaccine (adenoviral vector)
(10 April 2020), A randomized, double-blinded, placebo-controlled phase II clinical trial for Recombinant Novel Coronavirus (2019-nCOV) Vaccine (Adenovirus Vector)
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