What changes with the approval of updated anti-Covid vaccines by the FDA
The US FDA has given the green light to vaccines from Pfizer/BioNTech and Moderna adapted to Kraken, the Omicron XBB.1.5 variant. Here's what he said and how the infections are going
The Food and Drug Administration (Fda) has said yes to the updated vaccines from Pfizer/BioNTech and Moderna. Both are formulated to counteract the latest Omicron XBB.1.5 variant, commonly known as the sea monster Kraken .
In the European Union, the Medicines Authority (EMA), and in Italy the Italian Medicines Agency (AIFA), have for now only authorized the Pfizer/BioNTech vaccine, but the response on the adapted vaccines is also expected by mid-September of Moderna and Novavax.
THE INCREASE IN CASES AND THE FDA APPROVAL
In the United States, the approval of the Pfizer and Moderna vaccines updated to XBB.1.5 comes at a time when hospitalizations in the country have increased by about 16%, in line with the upward trend that began in late July. However, according to virologist Anthony Fauci, it is truly unlikely that there will be a "tsunami " of cases.
To be administered, the vaccines must now receive the green light from the Centers for Disease Control and Prevention (CDC) which will meet today but in the meantime the FDA has approved them for everyone aged 12 and over and, for emergency use, for children aged 6 months to 11 years.
However, for the moment, the updated version of Novavax has not received the approval, whose shares, consequently, closed yesterday down by almost 13% . Unlike those of Pfizer and Moderna with mRNA, its is a protein vaccine.
Furthermore, last year's vaccines from Pfizer and Moderna are no longer authorized in the US.
VARIANTS AND PROTECTION OF NEW VACCINES
Although XBB.1.5 is no longer the most widespread variant either in the United States or in Europe, where Eris (EG.5) dominates as in much of Asia, the vaccine manufacturers have declared that the shots will still offer protection . The peak in cases would be due to EG.5, while XBB.1.5 is decreasing in the United States.
Both Pfizer and Moderna also said that their updated vaccines produced “a strong immune response against BA.2.86,” the so-called Pirola , the one specially watched for its many mutations . In reality, only Moderna published the first data last Thursday.
But we are already looking further ahead and according to doctor Deborah Birx , former White House Covid-19 response coordinator during the Trump administration, the United States should already be developing new targeted vaccines by January.
WILL THE END OF THE HEALTH EMERGENCY MAKE BIG PHARMA JOY?
The distribution of these updated vaccines will be the first since the United States declared the health emergency over in May. This means the government will now shift the distribution of vaccines to the private market, where manufacturers will sell them directly to healthcare workers at higher prices. In the past, however, the government purchased them from manufacturers at a discount and distributed them for free.
However, private insurance and programs like Medicare , which cover the vast majority of Americans, are supposed to provide the vaccines for free, and the Biden administration's Bridge Access Program aims to distribute them to uninsured people as well.
However, it remains to be seen how many will want to receive it. According to the CDC, in fact , only about 17% of the US population – about 56 million people – have received the latest Pfizer and Moderna boosters since they were approved in September 2022.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/cosa-cambia-con-lapprovazione-dei-vaccini-anti-covid-aggiornati-da-parte-della-fda/ on Tue, 12 Sep 2023 09:19:44 +0000.