The government is not planning to roll out an untested Covid-19 vaccine

24th Sep 2020

Claim

The government is bringing in a law that means unlicensed, untested vaccines can be given to people and no one is liable if they go wrong.

Conclusion

This is not correct. The government was holding a consultation on whether it should change rules around unlicensed vaccines. Unlicensed is not the same as untested, and the manufacturer would still be liable if the product didn’t meet safety standards or is defective. Any vaccine given to the public will have to go through several stages of testing, regardless of this consultation.

We’ve seen a number of Facebook posts claiming that the government is planning to change the law to allow untested and unlicensed vaccines to be given to the public, in light of the Covid-19 pandemic.

This is not the case. The government is not planning on giving an untested vaccine to anyone.

Unlicensed and untested vaccines are not the same thing 

The government was, until 18 September, asking for responses to a consultation on whether it should change the rules around unlicensed vaccines, which it is already allowed to roll out in the case of public health emergencies such as a pandemic. The proposals would change certain aspects of the Human Medicines Regulations 2012, making it easier for the government to roll out a Covid-19 vaccine to a large number of people, faster than usual.

But an “unlicensed” vaccine (for Covid-19 or anything else) does not mean it’s not been tested. As we’ve written before, any vaccine rolled out to the public, unlicensed or not, still has to go through extensive clinical trials. This would include a Covid-19 vaccine. 

Licensing happens after the vaccine has gone through all three phases of pre-launch trials, which usually means the vaccine has already been tested on thousands of adults. We’ve written extensively about this claim here.

It’s not true that no one would be liable if there was anything wrong with the vaccine either. If the product doesn’t meet safety standards or is defective, then the manufacturer would still be liable. 

The consultation aside, it’s already true that if the government recommends the roll-out of an unlicensed product, manufacturers can’t usually be sued in civil court for the consequences. We’ve written an entire piece on this issue, which you can read here.

Although the consultation is now closed to responses, a decision on whether to change the regulations will likely take a while, and responses may take up to 12 weeks to be published.