REGULATORY NEWS UPDATE 3

1. Italian studies show COVID-19 shots less effective in Immunocompromised

COVID-19 vaccines are less effective on people with weakened immune systems, three small Italian studies show, which the studies' researchers say highlight the need to deploy booster shots for this group of vulnerable people.

The studies show that, on average, 30% of immunocompromised patients do not develop immunity to the virus after vaccination.

The remaining 70% respond to the vaccine, especially after the second dose, but to a lesser extent than healthy people and with differences from group to group, the Bambino Gesu Hospital in Rome, which conducted the three small studies, said in a statement on Monday, 4th October 2021.

The studies were conducted among a group of 21 patients with primary immunodeficiency disease, 34 children and young adults undergoing heart and lung transplants, and 45 young people with liver and kidney transplants.

The results indicate the need to increase the level of protection of the most vulnerable with booster doses, the hospital said.

"The results of our studies show that it is essential to protect the most fragile categories by administering the third dose of vaccine, calibrating the dosages or resorting to new adjuvanted vaccine formulations able to enhance the immune response to the virus and maintain it over time," said Professor Paolo Palma, Head of clinical immunology and vaccinology at the Bambino Gesu.

2. Europe's drug regulator said a booster shot of the Pfizer-BioNTech vaccine could be given to healthy adults

The European Medicines Agency, said on Monday, 4th October 2021 that a booster shot of the Pfizer-BioNTech coronavirus vaccine could be given to healthy adults at least six months after the second dose.

The agency said data showed that antibody levels increased in people age 18 to 55 with normal immune systems who had received a third dose of the vaccine. It is still assessing booster shots of the Moderna vaccine.

The agency also said that people with "severely weakened" immune systems could receive an extra dose of the Pfizer-BioNTech or Moderna vaccines as early as 28 days after a second dose. It is expected that an additional shot "would increase protection in at least some of the patients," the agency said.

The recommendation is based on studies showing that an extra dose of those vaccines could increase the ability to produce antibodies in organ transplant recipients.

3. WHO backs malaria vaccine rollout for Africa's children in major breakthrough.

The World Health Organization (WHO) said on Wednesday, 6th October 2021 the only approved vaccine against malaria should be widely given to African children, potentially marking a major advance against a disease that kills hundreds of thousands of people annually.
The WHO recommendation is for RTS,S - or Mosquirix - a vaccine developed by British drugmaker GlaxoSmithKline

4. Nordic countries are restricting the use of Moderna's Covid vaccine.

Here's why Finland, Denmark and Sweden are limiting the use of Moderna's COVID-19 vaccine in young people over concerns around rare cardiovascular side effects, myocarditis; a condition where the heart muscle becomes inflamed.

Finland's national health authority, THL, announced Thursday, 7th October 2021 that it would pause the use of Moderna's Covid vaccine in young men. All males aged 30 or younger would be offered the Pfizer-BioNTech vaccine instead, THL said.

The decision by THL followed announcements from its Swedish and Danish counterparts on Wednesday, 6th October 2021 that both would be restricting the use of the Moderna vaccine in similar demographics.

In Sweden, the use of the vaccine will be stopped in people born in 1991 or later, while Denmark is pausing the Moderna shot in everyone under the age of 18.

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