Covid vaccine goalposts change yet again

New vaccine to be single dose for adults (irrespective of vaccine history)

EU regulators have recommended authorising an updated COVID-19 vaccine from Pfizer and its German partner BioNTech which targets the dominant XBB.1.5 variant of Omicron, putting it on track to become the third adapted shot by the two companies to be approved in the bloc.

The vaccine, dubbed Comirnaty, is to be used for preventing COVID-19 in adults and children from the ages of six months.

With respect to adults, anyone can take this single shot vac, irrespective of whether or not they have been previously vaccinated against Covid-19. This is a change from the past where boosters were only offered people who had previously received the double shot.

With respect to children however, those aged from six months to four years “can take one or three doses of vaccine” depending on how many prior doses they have received.

Reuters reports that adults and children from five years of age who require vaccination should have a single dose, “irrespective of their COVID-19 vaccination history.

“Vaccine makers including Moderna and Novavax have also created versions of their shots aimed at the XBB.1.5 subvariant of the virus.

“Pfizer and BioNTech have also filed applications with the U.S. Food and Drug Administration requesting approval of the updated vaccines and a decision is expected in coming days”.

Following months in which there has been very little information on Covid-19, the virus is ‘back in the news’, with around 6,000 pharmacists about to ‘participate in free training on the administration of the vaccine, in order, says the blurb, to “assure elevated patterns of efficiency and effectivity”.

The government has also announced that it will be paying community pharmacies  administering free flu and Covid shots to the over-60s this autumn (the campaign begins during second week of September) €2.5 per vaccine.

How will the new system work?

According to ECO online, “an online platform is being prepared to allow vaccines to be booked via the internet, with participating pharmacies and their available opening hours.

“Eligible users will be able to call their pharmacy and make an appointment, or go to the pharmacy in person” and do so. 

There is also the possibility of pharmacies operating the ‘Open House’ policy that health centres operated during the pandemic.

There will be a number of ‘wrinkles’ along the way: the vaccines are ‘multidose’, meaning if just one person doesn’t turn up when programmed, dosages can be ‘lost’ (as the vaccine has a short time limit). There may also be issues with people who want to be vaccinated, but are found to have had Covid ‘too recently’ to be eligible.

ECO stresses that “Portugal is registering a growing number of new cases of Covid-19” (citing the latest 31 cases registered per 100,000 inhabitants). There is no suggestion that any of these cases has been serious.

Meantime, the country’s official Nurses body (Ordem dos Enfermeiros) is resisting the delegation of vaccination to community pharmacies, saying that vaccinations are not in pharmacists’ job description.

EMA’s recommendation for the roll-out of these vaccines provides the information that they “are adapted so that they better match the circulating variants”.

In other words, the vaccine won’t simply protect against Omicron’s XBB.1.5, it theoretically protects against others in circulation.

“Since the first authorisation of Comirnaty, authorities have gained extensive knowledge about the safety of the vaccine. Side effects are typically mild and short-lived. They include headache, diarrohea, joint and muscle pain, tiredness, chills, fever and pain or swelling at the injection site. More serious side effects may occur rarely (see below).

EMA’s recommendation for roll-out of these shots is now dependent on the European Commission issuing a legally-binding decision (clearly a formality).

“As with other COVID-19 vaccines, national authorities in EU Member States will determine how to use this vaccine in national vaccination campaigns, taking into account factors such as infection and hospitalisation rates, the risk to vulnerable people and vaccine availability.

How the vaccine works

Adapted vaccines work in the same way as the original vaccines“, says EMA (neglecting to say whether they have fixed the transmission issue, or the issue that vaccinated people still find themselves contracting Covid-19).

“This vaccine contains molecules called mRNA which have instructions for making the spike protein of the Omicron XBB.1.5 subvariant. The spike protein is a protein on the surface of the virus which the virus needs to enter the body’s cells and can differ between variants of the virus. 

“When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike proteins. The person’s immune system will then recognise this protein as foreign and activate natural defences – antibodies and T cells – against them.

“If, later on, the vaccinated person comes into contact with the virus, the immune system will recognise the spike protein on its surface and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, preventing its entry into the body’s cells and destroying infected cells.

Comirnaty was first authorised in the EU in December 2020, with adapted versions targeting BA.1 and BA.4-5 strains obtaining further authorisation in September 2022.

Serious side effects

Serious side effects may indeed be rare; but that is cold comfort for those affected by them. A number of countries operate compensation schemes for ‘vaccine damaged’ and here in Portugal there have been conflicting views on whether children and healthy adults even need to be vaccinated.

As more and more ‘news’ of the virus returns to the nation’s media pages, a political party in Madeira has launched a poster campaign, suggesting the country’s excess mortality – a phenomenon flagged throughout Europe – is linked to the mass vaccination campaign which ran during the pandemic.

The main positive in the debate is that this time round no one is being ‘obliged’ to vaccinate. These free vaccines – to be administered in the over-60s with free flu jabs – are voluntary, and no one has been told that they cannot travel, or go to a restaurant/ visit someone in hospital if they haven’t had them.

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