Coronavirus: The step by step guide to getting a drug approved

Hind Al Soulia - Riyadh - There are about 160 coronavirus vaccines in various stages of production with differing degrees of confidence and expectations as governments and pharmaceutical companies race to find a treatment for Covid-19.

It is hoped one of them will be a sterilising vaccine that can wipe out Covid-19 but it’s also possible none will be effective enough to go into production.

In the high-risk, high-cost world of drug development it’s also possible a second generation of medicines will build on the success of the current race.

And the rules for finding the vaccine are changing as testing systems that normally take years to complete are cut to months.

Professor Lawrence Young, a virologist at Warwick University who specialises in how diseases can develop, explained.

“There are five stages in producing and developing a vaccine – discovery research, pre-clinical, clinical development, regulatory review and manufacturing and delivery.”

Discovery research tries to understand how a virus behaves and the likely immune responses. This stage normally takes two to five years.

Once scientists have identified a potential vaccine and immune response, they move to the pre-clinical stage.

In the pre-clinical stage scientists can help identify a type of vaccine development.

“The Oxford vaccine is a viral vector where they have stitched in the coronavirus model into another harmless virus that is good at delivering the vaccine,” Prof Young said.

“It uses the surface spike of protein but does not give you a heavy dose.

“The tried and tested approach is ‘make the virus and inactivate it’.“

The pre-clinical stage also uses animals and laboratory testing to help assess the potential drug’s safety.

Phase 3 assesses if the vaccine reduces the diseases and infection

Clinical research is where all new medicines go through three phases of testing.

“Phase one is about safety testing. We take a small number of people, perhaps 10 or 15, and you check a dose and make sure it does not have severe side effects,” Prof Young said.

“We are not looking at the different outcomes, just making sure it is safe in humans and can we identify a safe dose.

“Phase 2 is checking it has the right immune response. At the moment, we don’t know what an effective immune response is.

“Several hundred people take part in this phase. ”For the Oxford vaccine trial they had more than 1,000 people.

“Phase 3 assesses if the vaccine reduces the diseases and infection. This is a trial to see if the vaccine is going to be effective against the disease.”

Regulatory review is the final stage in the approval process and data from all the human trials are assessed by national or international regulatory bodies. In the UK, that’s the Medicines and Healthcare products Regulatory Agency and in the EU, there is the European Medicines Agency. The US has the Food and Drug Administration.

Once approved the final stage is manufacturing and delivery, which can involve building new factories or labs to produce the drug in sufficient quantities to meet the demand.

This is a time when the pharmaceutical company invests in infrastructure to make the new drug and makes sure there’s a supply route to get it into hospitals and surgeries.

Why are things moving so fast with the coronavirus trials?

Normally, each stage of development can take years, but less than a year after the first coronavirus patient was identified 160 vaccines are in development. Most will not reach production.

Prof Young explained an influx of government money, streamlined processes and parallel operations all helped speed up the vaccine process.

Government money is helping reduce the risks for the pharmaceutical companies, which usually carry that all until they can eventually sell a successful drug.

Now factories are being built on the hope that a drug will become approved as a successful vaccine – a risk that normally would not be taken on until after the drug is approved.

Prof Young added that the hope was to eventually find a sterilising vaccine where you take it once and do not need booster shots.

He said it was also possible that a second generation of drugs would be needed to achieve that goal.

Of the 160 vaccines in development, he said, four are in phase three, 12 in phase two and 18 in phase 1.

Professor Sarah Gilbert, who is leading the Oxford vaccine team, told the BBC’s Today programme, that it was too early to know if their candidate could become a sterilising vaccine.

“We can only know that when the phase 3 trials have got much further along, when we have a lot of people vaccinated, half with coronavirus vaccine and half with another vaccine, and we start to count the number of infections in those trials, and that’s very unpredictable,” she said.

“It depends on the cases that are happening in the areas where vaccinations are taking place. Case numbers have been going up and down in different countries, so it’s very hard to understand when we’ll get those results."