EMA authorises third Covid vaccine dose in general adult population as Spain starts on elderly and immune-compromised

A THIRD Covid vaccine dose has been approved by the European Medicines Agency (EMA) for the general population following successful trials on volunteers aged 18 to 55 inclusive, although each member State will be allowed to decide for itself whether or not to do so.

Spain has started already on giving a third jab to all elderly residents – but not staff – in nursing homes, and to the immune-compromised, such as transplant patients, people in cancer treatment, people with HIV or AIDS, or with other health conditions that make them especially vulnerable to infection.

According to the EMA, the third dose should be given six months after the second, but it has authorised this in the immune-compromised for 28 days.

Health minister for Spain, Carolina Darías, says her department has 'always been guided by the EMA', but has not as yet made a decision about a third dose for anyone other than those currently receiving it.

The Pfizer jab was the one trialled, given that its creators have always said a third injection was necessary for full immunity and have assured that those inoculated with it 'are not infectious'.

Volunteer adults aged 55 and under were found to have an 'increased level of antibodies' protecting them from the effects of the SARS-CoV-2 virus, the EMA confirmed, but the European Union does not intend to make it compulsory for all 27 member States to administer it.

Countries should decide for themselves 'based upon information supplied by Pfizer', but 'also upon the possible risks of adverse effects', which are currently under investigation.

The Pfizer vaccine has not, to date, shown any potentially fatal side-effects, or any long-term life-limiting ones – most of those who received it and reported any type of reaction said the first dose caused them few or no problems, but the second gave them a mild headache, dizziness and fever for a day or two, and up to a week of tiredness and general weakness in upper limbs, potentially forcing them to take between a day and a week off work, but that once these had worn off, they were completely back to normal.

Studies are in place concerning effects of the different Covid jabs on menstruation – a survey in Spain found 14,000 women reported changes, ranging from cycle disruption with periods coming less often or more frequently, and in some cases, more severe pains – but so far, they do not appear to be long-term and have not been found to affect fertility.

A handful of isolated cases of coronary inflammation, or swelling of the heart muscle, have been reported worldwide following the Pfizer injection, but all those known have been successfully treated, and anyone who experiences unusual chest pains or shortness of breath, or who has an existing heart complaint, has been advised to seek emergency medical attention.

Spain says it is not yet considering summoning the entire population for a third dose, but is focusing more on communities who are most at risk and should be a priority for an extra immune boost, such as the elderly and those with physical illnesses that may either make them more vulnerable to catching Covid, or cause them to be more seriously ill with it if they do.

The EMA has made a clear distinction between 'extra dose' and 'booster dose', with the first being indicated for those who have not achieved sufficient levels of immunity through the first two or, in the case of the single-dose Janssen, their sole injection, and the second being for those who responded well to the initial cycle but who will need a reinforcement over time as the effects wear off and antibodies deplete.

Immune-compromised patients can have a third dose 'at least 28 days after the second', according to the EMA, but says it has not as yet been able to amass solid evidence that people in this situation would ever, in fact, be able to produce enough antibodies, irrespective of how many jabs they are given.

This research is likely to take much longer, since it will need to encompass a huge variety of health conditions.

The European Centre for Disease Control (ECDC) strongly recommends that, in addition to the nursing home residents and immune-compromised patients whom Spain is already giving a third dose to, this be administered to all persons aged 80 and over, and to healthcare and care home staff, especially as autumn and winter tend to bring an increase in conditions caused by different Coronavirus strains – of which even the common cold is one – and that the highly-contagious and aggressive 'Delta' variant of SARS-CoV-2 remains rife worldwide.

It is likely Spain will consider these communities next, and then go on to decide whether to proceed in a like manner with key public-facing workers such as police and other emergency services and the general population aged 65-plus, but no plans appear to be imminent for younger adults in good physical health who do not face an elevated risk of contagion due to high levels of contacts.