Novavax: Vaccine volunteer 'in limbo' over booster jab

https://www.bbc.co.uk/news/uk-england-tees-58717604

Version 0 of 1.

Derek Robson fears he is entering the winter months with reduced protection against Covid

A man taking part in the Novavax Covid vaccine trial has accused the company of "washing their hands" of volunteers when it comes to booster jabs.

Derek Robson, 63, from Hartlepool, was vaccinated in November and would now be due a booster if he had an NHS jab.

However, his trial site is not offering them and he is unable to access a deployed vaccine booster via the NHS.

Novavax said it "empathised" with the concerns of participants in its trial and was urgently seeking guidance.

Last year thousands of volunteers, including two government ministers, signed up for trials of the vaccine being developed by the US-based company.

In January positive results for its UK trial were posted, but it has not yet filed for approval and the trial remains ongoing.

Mr Robson, who took part at the University Hospital of Hartlepool site, said: "I had my second vaccine in November 2020 and the government is now advocating a booster jab after six months.

"Novavax have made no effort to contact anyone advising them that the effectiveness of the vaccine will wear off and I now feel that I'm entering the winter months without any, or reduced, protection against Covid."

Volunteers 'abandoned'

Participants have received letters saying that Novavax "could not provide guidance on the safety of... a booster of an approved vaccine after having previously received two doses of the Novavax vaccine ... because data to support such advice does not exist".

Mr Robson said: "They appear to have abandoned the volunteers.

"My experience to date suggests Novavax trial volunteers cannot get any alternative vaccine as no-one wants to take any responsibility.

"It seems that both Novavax and the NHS have washed their hands of the trial volunteers.

"They both make noises about how valuable a contribution we have made, but each of them are trying to pass the responsibility for a decision on a booster to each other."

Novavax was shown to be 89.3% effective at preventing Covid in its Phase 3 UK trial

As well as concern over boosters, the delay in filing for approval has caused problems for volunteers wishing to travel abroad as Novavax is only recognised by a handful of countries.

Novavax said in a statement: "[We are] grateful to clinical trial participants, who are a primary reason that some countries are able to begin reopening during this unprecedented global pandemic

"We empathize with their concerns - and challenges - as the world begins to reopen.

"The UK government and Novavax are of the position and are making the case that those who participate in clinical trials should be treated in the same manner from a public health perspective as those who have received a deployed vaccine, and we continue to advocate for this.

"Regarding boosters, we have sought urgent guidance from NHS/Joint Committee on Vaccinations which they are actively considering, and will be sure to share updates as we have them."

The Department of Health and Social Care said: "We are urgently working to resolve this issue and any decisions will be communicated directly to the participants and trial chief investigators as soon as possible. "

Follow BBC North East & Cumbria on Twitter, Facebook and Instagram. Send your story ideas to northeastandcumbria@bbc.co.uk.