What has to happen before a Covid vaccine can be used?

There has been lots of news about potential vaccines – but do we know when any will be delivered?

No. There are serious hurdles to be overcome first, and they are important to ensure the potential vaccine is safe.

Who will grant the licences?

There are regulatory bodies all over the world but the main ones for these vaccines are the Food and Drug Administration in the US, the European Medicines Agency, and the Medicines and Healthcare products Regulatory Authority in the UK. The UK would normally wait for EMA approval, but the government has passed legislation to enable the MHRA to do it alone, as it will post-Brexit anyway, in the interests of speed.

What must the regulators do?

They will look at all the data from all the trials to ensure they have been conducted properly and that there is robust evidence the vaccine works and does not cause serious side effects. It’s a bit like marking the companies’ homework to make sure they have got it right. They will also look to see that the vaccine can be safely manufactured in accordance with a set of standards called Good Manufacturing Practice. That relates to the strict sterilisation and hygiene standards required.

There is a need for speed, but are the regulators going to rush this?

They say absolutely not, and emphasise that safety is the most important thing – more so than how well the vaccine works. Every part of the research and development and authorisation processes has been sped up, but mostly by overlapping them. So the regulators have been given all the trial data as it comes along. They have the data from the early lab work, as well as the animal research and the safety trials in humans and have been conducting what they call rolling reviews. So when the final large-scale trial results from tens of thousands of people come in, they can add those to what they have, and hopefully make a faster decision. Manufacturing has been taking place even while the vaccines are being trialled, which is a financial risk, because if the vaccines had failed, all the stocks would have had to be destroyed.

How long will it take the regulators to approve a vaccine?

Usually, from development to authorisation takes anything from months to several years. The actual time the MHRA or EMA spend poring over the data and asking questions is stipulated in the rules as up to 210 days. But the rolling reviews should cut the time substantially and the UK government has said it will ask for emergency authorisation under regulation 174, which speeds up the process but requires review within a year to ensure safety.

The Guardian

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