HPRA Opening Statement — Department of Health COVID-19 Press Briefing — 18 February 2021

News Category: Regulatory news

Date: 19/02/2021

Dr Lorraine Nolan, Chief Executive of the HPRA, spoke at the Department of Health COVID-19 press briefing on 18 February 2021 to provide an update on the safety monitoring of COVID-19 vaccines. The opening statement is available to read below.

I would like to provide you with a brief update in respect of ongoing safety monitoring of COVID-19 vaccines. The following is the third such update now published by the HPRA and provides an overview of Irish reports of suspected side effects notified to us up to 11 February.

Our latest report has been published this evening on the HPRA website.

Over the last number of months, we have been actively encouraging the public and healthcare professionals to report any suspected side effects experienced following vaccination.

To date, a total of 2103 reports have been received. Over 95% of these related to the use of mRNA vaccines as would be expected given their predominant use in the vaccination programme so far. This is in the context of approximately 260,000 doses administered during this period.

Similar to our previous safety briefings, all reports received for these vaccines are consistent with the known safety profiles established during clinical trials for these vaccines, and as outlined in the patient information leaflets.

Of the reports notified to the HPRA, the most commonly reported suspected side effects include dizziness, headache, tiredness, as well as itching and/or rash at the site of injection. These were mild to moderate in nature and resolved, or were resolving, at the time of reporting.

Additionally, for mRNA vaccines, we have seen a trend for increased frequency or intensity of side effects reported after the second dose, particularly in younger age groups. This is fully consistent with the known safety profile for these vaccines demonstrated during clinical trials.

There has been a small number of reports of people experiencing suspected anaphylaxis following vaccination with the Pfizer/BioNTech vaccine. All have now fully recovered. Anaphylaxis is a very rare side effect associated with most vaccines and all vaccinators, as standard, are fully trained to deal with such an occurrence. Widespread use of the mRNA vaccines internationally now suggests an incidence rate in the region of 1 in 100,000.

We have also received reports describing facial paralysis, including cases of suspected Bell’s palsy, or conditions associated with temporary weakness in the muscles on one side of the face. As always, we will continue to monitor these cases to establish that these symptoms have resolved. The number of reports of facial paralysis received so far is in line with the expected rate at which these conditions occur naturally and does not currently suggest an increased risk following vaccination.

Sadly, fatalities from natural causes or background illnesses will occur in the period following the administration of a vaccine, and will continue to do so over the course of any vaccination campaign. We encourage healthcare providers to report any death of an individual following vaccination, irrespective of whether they believe the fatality was related to the vaccine or not.

We have received reports of elderly individuals, with underlying health conditions, unfortunately passing away in the period following vaccination. We have carefully reviewed these reports, and based on the information provided, there have been no safety concerns identified regarding the use of any vaccine.

A high proportion of people vaccinated so far are elderly, many of whom will also have pre-existing medical conditions. Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the number of people in this cohort being vaccinated.

The EMA, with involvement of the national authorities including the HPRA, other major regulators globally and the WHO have completed separate comprehensive reviews of similar reports internationally. All of these reviews have concluded that the available data does not suggest a link with COVID-19 vaccines.

Globally, regulators will continue to receive reports of fatalities in the period following vaccination, which will be sent to them out of an abundance of caution.

For those who might not be familiar with safety monitoring, and the type of information I have outlined, I would like to stress that the receipt of reports of suspected side effects experienced following vaccination is a very positive and important component of our process. However, it is vital that this information is not misconstrued or incorrectly interpreted. Reports of suspected side effects alone are not sufficient to prove that the effect has been caused by the vaccine, and should not be used in isolation to compare the safety profile between vaccines. All reports received for each vaccine are compiled into a cumulative data set globally that undergoes extensive analysis before any proven association with a vaccine can be made.

Reassuringly, the nature of reports we have received to date further confirm the safety profile established for these vaccines. At this point globally, tens of millions of mRNA and AstraZeneca vaccine doses have now been administered, and we continue to be encouraged by the safety profile demonstrated by these vaccines.

But it’s also important that when discussing possible side effects from vaccination, that we don’t lose sight of the significant, often life-threatening effects of COVID-19 itself.

What we have observed to date, clearly shows that the benefits of COVID-19 vaccination, in terms of protection from disease, far outweigh the risks of potential side effects which, for the overwhelming majority, are mild and short-term.

And finally, coming to other positive developments, you may have seen, just this week, the EMA has received another application for conditional marketing authorisation from Janssen for a single dose vaccine, with a decision expected in mid-March. We have also seen the start of rolling reviews for vaccines from Novavax and CureVac, respectively. These are very encouraging developments, as the availability of further vaccines, in combination with our existing public health measures, will continue to be our main tools to controlling the current pandemic.

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