THE EUROPEAN MEDICINES Agency is expected to give the green light to Johnson & Johnson’s one-dose Covid-19 vaccine today, but this latest ‘game-changer’ jab may also find it difficult to meet EU supply expectations next month.
Because of its one-dose regime and the fact that it can be stored at fridge temperatures – as well as high efficacy results in trials – governments across the EU have been eagerly awaiting its approval as they struggle to roll-out vaccinations on a large scale.
This week HSE CEO Paul Reid said 3.8 million vaccine doses are expected to be delivered to Ireland in Q2, including the 600,000 Johnson & Johnson doses.
The health service has been challenged in the roll-out by unexpected delivery shortfalls from all three manufacturers with EU-approved vaccines. Reid acknowledged that there have been up to 17 changes to vaccine plans so far due to these supply issues, as well as sequencing adjustments.
Now it appears an 18th change is on the horizon, as the bulk of Johnson & Johnson’s deliveries are now not expected to arrive in Ireland until June.
This week Reuters reported that Johnson & Johnson has told the European Union it is facing supply issues that may impact on its ability to deliver the level of vaccines expected in the EU in the second quarter of this year.
It is reported that the company told the EU that issues with the supply vaccine ingredients and equipment means it was “under stress” to meet its goal of delivering 55 million doses by the end of June. An EU official said the company had stated it was not impossible to meet the goal, but it showed caution.
Speaking to RTÉ’s News at One yesterday, Tánaiste Leo Varadkar said he knows the “slippage on timelines” has been frustrating for people and “undermines confidence”.
Varadkar said the information the government has is that while Johnson & Johnson will be able to provide the 600,000 doses as promised in the second quarter of the year, a significant percentage will not arrive into the country until June.
“Instead of it arriving in equal amounts in April, May and June, we now anticipate that there will be a relatively small amount arriving in April and then more in May and then the bulk of it in June,” he said. “So it’s the same amount, but it is a further delay unfortunately.”
In a statement in response to reports of supply issues, Johnson & Johnson said it has been “working directly with governments, health authorities and other companies to help end this pandemic”.
“To achieve our ambitious goals to deliver our Covid-19 vaccine candidate, we have focused on building a global supply network in parallel,” the firm said.
“We continue to start-up and activate new manufacturing sites as quickly as possible, such as the collaborations with Catalent, Reig Jofre and Sanofi Pasteur.
“As part of our commitment to transparency, we intend to provide another update to the European Commission and member states on our supply during our next meeting mid-March when the European Union Vaccine Steering Committee meets again.”
The company said it had reaffirmed its commitment, at the meeting with members of the EU vaccine steering committee last week, to deliver 200 million doses of the vaccine to the EU this year, starting in the second quarter.
Thierry Breton, the EU industry commissioner, has said the bloc is now on target to receive 100 million doses in each of the next three months, and possible further hiccups have been “integrated” into the planning.
“I forced companies to have many, many (contingency) actions in case something could go wrong,” Breton said.
He added that reported production shortfalls in the United States by Johnson & Johnson would not impact the EU’s outlook.
“Do not believe that because one company has a problem that overall it will jeopardise the whole programme. This is why it’s good to have today – or let’s say tomorrow – hopefully four vaccines to go, and soon five,” he said.
The Johnson and Johnson vaccine uses viral vector technology – the same approach as the Oxford/AstraZeneca vaccine. Viral vector vaccines use a modified version of a different virus – the vector – to deliver instructions to human cells.
The Johnson and Johnson vaccine uses a common cold-causing adenovirus which has been modified so it cannot replicate.
This ‘vector’ virus tells human cells to create the spike protein of the coronavirus. It prepares the immune system, training it to respond when it does come across SARS-CoV-2, the virus that causes Covid-19.
Unlike the two-dose vaccines we’re using currently, this vaccine only requires one dose. The vaccine can also be stored at fridge temperatures which opens it up to use in settings like GP surgeries, pharmacies and mass vaccination centres.
The manufacturer has said that its large Phase 3 trial included “significant representation” from those who are over the age of 60. The EMA, on approval of the vaccine, will provide guidance to member states on the use of this vaccine in specific age cohorts.
In large clinical trials, the vaccine’s efficacy against severe disease was 85.9% in the US, 81.7% in South Africa and 87.6% in Brazil.
This vaccine was only due to make up about 15% of Ireland’s overall stocks in the second quarter of the year, so these shortfalls are not likely to have a catastrophic impact on the vaccination programme.
However the health service has been making plans based on the assumption that it would have access to large supplies in Q2 of a one-dose vaccine that could be used in community settings as it ramps up the programme. These supply issues may mean another reshuffle of the plans.
Yesterday the Tánaiste said despite supply issues, the government still expects “roughly a million [doses] or just under” in April, 1.25 million May and 1.68 million June.
“This does come with a health warning that deliveries are out of our control and schedules change regularly,” he added.
When asked about the impact of potential shortages, the HSE said as the Johnson & Johnson vaccine has yet to receive EMA approval “we are awaiting confirmation of forecast delivery dates and volumes”.
“The HSE is putting plans in place in the event of EMA approval to ensure the swift distribution of the vaccine, if and when it is made available.”
- With reporting from AFP.
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