The pharmaceutical industry is working at a remarkable speed to develop a safe and effective vaccine against the coronavirus that is accessible to everyone who needs it.
Conventionally, vaccine development takes around 10 to 15 years, with the world record of developing a fast track vaccine currently standing at four years.
This time, with the world in the midst of a pandemic, countries are pooling resources to accelerate efforts to reach the common goal. Last week, world leaders pledged €7.4 billion at a fundraising telethon, with Malta’s share at €400,000.
Clinical pharmacist Elena Marie Mifsud says there is a possibility the vaccine will be available in 12 to 18 months – depending on the success of clinical trials designed to ensure it triggers sufficient immune response without resulting in side effects or long-term complications.
How close are we to having a vaccine?
Vaccine creation, Mifsud explains, is a complex process that involves various stages: the identification of potential targets that will elicit an optimal immune response, laboratory assays (investigative procedures), animal models and human trials. This would be followed by an approval from the regulatory bodies and then production in large volumes.
Vaccinations are a cornerstone of public health
However, since COVID-19 is a new virus, things are rather complicated.
“Up to last week, new information was coming out of research labs updating the structure of the novel coronavirus, with an American-British team documenting previously unknown details about the virus which may provide vaccine developers with important clues on how best to target it,” says Mifsud, who is health services executive at Brown’s Pharmacy.
As at May 4, there were 120 vaccines in the pipeline, 10 of which moved to more advanced testing and are currently performing active clinical trials.
The current lead candidate is a Chinese biotechnological company that has reached phase two of the clinical trial, where the vaccine is currently being tested on healthy volunteers and will be continuously followed up in the six months that follow.
What happens after a vaccine is approved?
The availability of a vaccine is only the first step to ensure adequate immunity in a population. Another obstacle is the duration of immunity build-up following vaccination, Mifsud explained.
Details on the dosing schedule would be possible once a vaccine is identified, and it is unknown whether a booster dose would be required. If the vaccine produced is similar to the influenza vaccine, then yearly immunisation would be needed.
Malta has all the protocols in place in liaison with the European Union to ensure that it will be among the first countries to receive the COVID-19 vaccination available.
How safe will the vaccine be?
“Vaccinations are a cornerstone of public health, as they assist the body’s immune system to trigger protection against infections by producing antibodies that remember the pathogen and fight the disease,” Mifsud says.
Science and research have amply proven, over time, that the benefits of vaccination significantly outweigh the risk, and without vaccines many more deaths would occur.
In an ideal scenario, all the population would have access to the vaccine but prior to availability the safety and the effectiveness of the vaccine in vulnerable people cannot be determined.
In the absence of evidence on the safety and effectiveness in the vulnerable groups (children, pregnant women, immunocompromised patients and the elderly) the vaccine would initially be administered to the population at large, in hopes of acquiring herd immunity that will, in turn, decrease the susceptibility of transmission to the vulnerable groups, Mifsud said.