First COVID-19 vaccine approval: How and when
Out of the on-going human trials, there had been no reports of adverse side effects, or death among any of the volunteers. Moreover, many of the research teams involved have actually reported “encouraging results.” These are good signs.
But not so fast. Vaccine trials on humans are notoriously laborious and time-consuming (expensive too), based on the so-called “gold standard” in clinical research — randomised, placebo-controlled and double-blind studies.
And it’s for obvious reasons: the shots will land in the arms of hundreds of millions of healthy people — so they better be really safe and effective.
When will they be approved? There are signs it may happen soon, based on the following:
- Many vaccines are now in Phase III trials, including the one being done in the UAE.
- Governments have poured billions of dollars into COVID-19 vaccine research, involving thousands of scientists.
- Extensive trials are being done in six continents on thousands of volunteers.
- There’s a pressing need for an antidote to COVID-19, the illness that has kept us all hostage.
Q: Is there a COVID-19 vaccine approved for COVID-19 use by humans today?
Yes. China’s military has approved a coronavirus vaccine for use within its ranks. The jab has been developed by the People’s Liberation Army research unit and CanSino Biologics, the company said on Monday (June 29).
Reports have it that China’s Central Military Commission approved the use of the vaccine on June 25. The limited approval is good for one year. It’s not been approved for general public use yet.
Hong Kong-listed CanSino Biologics said in a filing to the stock exchange that data from clinical trials showed the Chinese military vaccine had a “good safety profile” and potential to prevent disease caused by SARS-CoV-2.
Q: What is “Operation Warp Speed”?
Operation Warp Speed (OWS) is a US government programme to speed up the development of COVID-19 vaccine for use by its citizens. It aims to deliver 300 million doses of COVID-19 vaccine by January 2021.
The scheme seeks to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
Q: How many vaccine candidates are under OWS?
In May, people behind “Operation Warp Speed” revealed they picked 14 candidates and planned to advance “about eight” to clinical trials. New York Times reported on June 3, citing Trump senior officials, that the list had been narrowed down to five.
The Trump administration has given AstraZeneca, Johnson & Johnson and Modern billions of dollars worth of vaccine production contracts. The deal with AstraZeneca is $1.2 billion. The two other major contracts (Johnson & Johnson and Moderna) total nearly $500 million each.
Q: What agency approves a new vaccine in different countries?
Different countries follow strict regulations for vaccines, based on criteria of the WHO Global “Benchmarking Tool”:
- UAE – UAE Ministry of Health, Health Authority – Abu Dhabi; Dubai Health Authority
- US – Food and Drug Administration
- India – Central Drugs Standard Control Organization (CDSCO)
- China – China Food and Drug Administration
- UK – Medicines and Healthcare products Regulatory Agency
- Pakistan – Drug Regulatory Authority of Pakistan (DRAP)
- Canada – Therapeutic Products Directorate (TPD), under Health Canada
- South Africa – The Medicines Control Council (MCC)
- Philippines – Food and Drug Administration, Philippines
Q: How many leading vaccine candidates are there today?
There are more than 130 vaccine candidates listed by the WHO. The US National Institutes of Health (NIH) has reviewed 50 candidate COVID-19 vaccines. Results of the review have not been made public yet.
There are five from China, 10 from India, at least one each from the UK, Thailand, Mexico, France, among others. The US government is working with three biotech firms including AstraZenera, J&J and Moderna.
Moderna is set to kick off Phase 3 clinical trials (30,000 volunteers) this July, and is one of the most advanced on human trials, though a “delay” of Phase III was reported, for reasons yet uknown. Still, the trials will go ahead this month, and results are expected “in a few months,” according to a top NIH official.
AstraZeneca started their Phase 3 trials in early June 2020. J&J announced in June their early-stage human trials will start this month (July 2020).
What is the US FDA vaccine approval process?
The US Center for Biologics Evaluation and Research (CBER), under the FDA, is responsible for regulating vaccines in the US. Vaccine clinical development follows the same general pathway as for drugs and other biologics.
What is the first step in holding clinical trials?
In general, a sponsor who wishes to begin clinical trials with a vaccine must submit an Investigational New Drug application (IND) to FDA. The IND describes the vaccine, its method of manufacture, and quality control tests for release.
Also included are information about the vaccine’s safety and ability to elicit a protective immune response (immunogenicity) in animal testing, as well as the proposed clinical protocol for studies in humans.
What are the trial phases?
Pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases, as is the case for any drug or biologic.
Initial human studies, referred to as Phase 1, are safety and immunogenicity studies performed in a small number of closely monitored subjects.
Phase 2 studies are dose-ranging studies and may enroll hundreds of subjects.
Finally, Phase 3 trials typically enroll thousands of individuals and provide the critical documentation of effectiveness and important additional safety data required for licensing.