- The European Union's drugs regulator said on Monday that individuals with a weakened immune system should get a third dose of a Covid-19 vaccine from Pfizer-BioNTech or Moderna.
- The EU joins like-minded countries such as the United States, Britain and Israel where regulators have approved the use of Pfizer-BioNTech boosters.
Third Dose Vaccines For People With Weak Immunity Supported By EU Regulators
Throughout the pandemic, we witnessed a majority of immunocompromised people fighting for their lives in ICU wards post-infection of Covid-19. Now, there's some great news for them! The European Union's drugs regulator said on Monday that individuals with a weakened immune system should get a third dose of a Covid-19 vaccine from Pfizer-BioNTech or Moderna. Following this, they've also mentioned that members states should decide if the wider population should have a booster. This long-awaited guidance came after several EU member states pre-empted the European Medicines Agency's (EMA) opinion and launched their own booster campaigns, although they vary widely over who is eligible.
The EU joins like-minded countries such as the United States, Britain and Israel where regulators have approved the use of Pfizer-BioNTech boosters. However, there seems to be no consensus among scientists about how broadly they should be rolled out. Albeit this, Israel is the outlier, deploying them across the whole population.
According to the EMA, people with a severely weakened immune system should be given a third dose of the Pfizer-BioNTech and Moderna vaccines at least 28 days after their second one. Both of these vaccines are based on so-called mRNA technology – at least 28 days after their second one.
The rationale behind this is the fact that many treatments for cancer patients or for people with organ transplants suppress the immune system, making them particularly vulnerable to a coronavirus infection with reduced help offered from vaccines. Italian studies revealed that Covid-19 vaccines are less effective on people with weakened immune systems.
Besides this, the EMA also said that a booster shot of the Pfizer-BioNTech vaccine could be considered for adults with normal immune systems around 6 months after the second dose. Later on, it was revealed that it was up to individual countries.
Looking at the current global state, governments are under pressure to revive their ailing economies, fight the more infectious Delta variant, and avoid further lockdowns this winter.
Actually, the EMA's ruling came right after the EU's infectious diseases centre warned last week that the region's coverage of vaccines was still too low. They also said that there was a risk of a significant surge in cases, hospitalisations and deaths over the next six weeks.
A virologist at the University of Leuven in Belgium, Marc Van Ranst, said that the decision on boosters was expected and would “legitimise the choices that some governments already made" in Europe. He further added that the EMA’s broad go-ahead could lead to further fragmentation of national decisions on the use of boosters, but more data was needed for the regulator to justify a more specific verdict.
Adding on to this topic is Antonella Viola, professor of immunology at the Italy's University of Padua, who said that the risk of heart inflammation from the mRNA vaccines, albeit rare, needed to be taken into account and the benefit of a booster for younger adults was questionable.
On a related note, The World Health Organization has criticised rich nations for hoarding COVID-19 vaccines for booster campaigns for larger population groups while poorer countries are struggling to roll out even first doses. This is completely unfair!
By allowing EU countries to decide the broader use of a booster is consistent with the EMA's earlier decisions in the pandemic – for instance, it largely left it up to member states to decide whether to restrict vaccines in the face of potential side effects. The EMA also stated that it hoped to see more data to underpin recommendation updates.
As for the vaccine companies, Pfizer and BioNTech presented data in their filings for their booster that showed levels of virus-fighting antibodies in the blood of vaccinated people wane over time and that a third shot was shown to cause a fresh surge in antibodies.
As per the words of researchers, immune cells, which are another important factor in immunisation, might confer longer-lasting protection against severe disease but their presence in the blood is more difficult to measure and more research is needed.
Viola from the University of Padua said that the young and healthy, in particular, should not get a repeat shot. She said, “The vaccines we have used protect everyone from severe disease with very high efficacy."
On 6th September, the EMA said that it had begun evaluating data submitted by Pfizer and BioNTech for a booster dose in people with a functioning immune system, with infections among vaccinated people adding urgency to its review. Apart from that, it also started evaluating last week the merits of a booster dose of Moderna's COVID-19 vaccine.