Unlicensed vaccines are not untested

22nd Sep 2020

Claim

After 18 September, the government is going to say that because there were no objections, they will roll out unlicensed vaccines.

Conclusion

Unlicensed (rather than untested) vaccines are already allowed to be rolled out by the government in circumstances such as a pandemic. The government is consulting on whether to clarify the rules around this.

 

These unlicensed vaccines will be administered by non-medical staff, such as your employer.

 

The government is consulting the public on whether to change the rules around who can administer certain vaccines, which may include some people who don’t normally administer them, including some who aren’t registered healthcare professionals. It does not specifically mention employers.

 

The public won’t be able to claim compensation if unlicensed vaccines damage our health.

 

They will in some cases. If the product doesn’t meet safety standards or is defective, then the manufacturer is 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.

Claim 1 of 3

A number of posts on Facebook and Twitter have used a link to a government consultation about vaccines to make a number of unfounded claims about government changes to how vaccines are introduced in the UK.

One such post reads:

“After 18th Sept, The Government are going to say they consulted the public and because there were no objections, we all want and consent to the rollout of unlicensed #vaccines, and that we are happy for non-medical staff to administer them and happy to accept we will not have the ability to ask for compensation if we face damage to our health.”

Although there is a genuine consultation happening on the subject of unlicensed vaccines, in general these claims are misleading. The government can already roll-out unlicensed (but not untested) vaccines during a public health emergency, and this consultation is proposing to clarify the rules around doing this.

As we can’t fact check what the government might do in future, here we’ve focussed on what the consultation document proposes doing.

Unlicensed does not mean untested

Some of these posts imply that unlicensed vaccines are untested, which is not the case. 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. Licensing is when experts within the national Medicines and Healthcare products Regulatory Agency (or the EU regulators, up to the end of the transition period) review the results of the trials. The standards of vaccines generally have to be much higher than those for medication to treat illnesses, as vaccines are usually given to healthy people to prevent disease.

What is the consultation about?

The government is asking people to respond to its proposals to change certain aspects of the Human Medicines Regulations 2012. The proposed changes would make it easier for the government to roll-out a Covid-19 vaccine to a large number of people, faster than usual.

There are five main proposed changes.

1. Temporarily authorising the supply of unlicensed, though not untested vaccines

Regulation 174 of the Human Medicines Regulations already allow the licensing authority to temporarily grant authorisation to an unlicensed medicinal product in the case of certain types of public health threat, such as a pandemic.

The government is not planning to change that regulation, but instead “To provide transparency, we propose to amend the [Human Medicines Regulations] to make it explicit that the supply of products, including COVID-19 vaccines, which is temporarily authorised under regulation 174 may be subject to conditions.”

So the plan is to make the rules around fast tracking unlicensed vaccines stricter, not looser.

The consultation goes on to say that “a COVID-19 vaccine would only be authorised in this way if the licensing authority was satisfied that there was sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine, in the particular context in which the licensing authority was asked to take that decision.”

2. Clarifying who has civil liability related to these vaccines

The government confirms that the decision to roll-out vaccination programmes for unlicensed vaccines will be taken nationally, and not by individual companies.

The consultation suggests clarifying some of the rules around who is liable for potential problems around unlicensed medicines. 

The government consultation document states that the law “does not provide complete immunity from civil liability.” And if the product is not found to meet safety standards or is defective, then the company will be liable. 

However, it’s already true that manufacturers “cannot generally be sued in the civil courts for the consequences resulting from the use of an unlicensed product, or a new use of a licensed product, that a national licensing authority is recommending in order to deal with certain specific health threats”, according to a government consultation document. 

We’ve written an entire piece on this issue, which you can read here.

3. Expanding who can administer vaccines

At the moment, only “doctors and other qualified prescribers” can administer vaccines. The consultation proposes expanding the group who can administer unlicensed vaccines to include people like “midwives, nursing associates, operating department practitioners, paramedics, physiotherapists and pharmacists”, and some others in related fields, who aren’t normally allowed to administer products without “full marketing authorisation” such as dieticians or radiographers

The consultation also recommends allowing “people who are not registered healthcare professionals, to safely administer a licensed or temporarily authorised COVID-19 or influenza vaccine”, which seems to be what the Facebook posts are referring to.

The consultation does not specifically mention employers.

The government adds: “Any additional workforce operating under the national protocol to administer vaccines will be trained and shown to be competent via an NHS and PHE approved training programme to ensure patient safety”.

4. Allowing promotion of unlicensed medicines to the public and healthcare professionals

The consultation document also recommends allowing temporarily authorised products, such as a future Covid-19 vaccine, to be advertised to the public and healthcare professionals. Currently, the promotion of any unlicensed medical products is banned.

5. Making provisions for wholesale dealing of vaccines

The government also proposes simplifying the rules around how vaccine supplies are moved between service providers, to allow any problems with supply between organisations to be swiftly solved. The consultation says these measures would be temporary.