Where are the Omicron vaccines at?
Pfizer, with its partner BioNTech, Moderna and more have been working for months on a new updated and more resistant vaccine against Omicron. Here's how the trials are going and what China is doing
Before arriving at a pan-coronavirus vaccine, i.e. effective against all variants, one will most likely have to move from one updated one capable of combating variants and sub-variants in circulation.
This is the prediction of the European Medicines Agency (Ema), with which Giorgio Palù, Emeritus Professor of Virology at the University of Padua, president of the Italian Medicines Agency (Aifa) and former member of the Cts also agrees.
WHAT THE EMA (AND PALÙ) SAID ABOUT THE NEW VACCINES
"The EMA recalled that for the entire population it is necessary to focus on vaccines updated to the circulating variants and sub-variants, as well as looking for a polyvalent vaccine against all coronaviruses in the long term. When the first ones are approved – they will probably be evaluated in September – they can be done ”, Palù reported in an interview with La Stampa .
WHERE ARE THE NEW VACCINES
Worldwide, Il Sole 24 Ore reported in April, "there are 271 preclinical studies, 147 vaccines in the first clinical tests and over a dozen promising candidates" for the new vaccines updated to the Omicron variant.
The work carried out by the scientists concerns both monovalent vaccines, i.e. only for Omicron and its sub-variants, and bivalent and therefore effective at the same time for the original Wuhan strain (like the current antidotes) and Omicron.
Pfizer / BioNTech and Moderna's research with mRna technology is oriented towards this second type, even if, according to Quotidiano Sanità , “it is not yet clear whether they will be more effective than those already in existence”.
AUTHORIZATIONS
Hopefully, the business newspaper wrote, in August the first requests for the authorization of a vaccine adapted against multiple variants will be submitted to both the EMA and the Food and Drug Administration (Fda). If successful, the vaccination campaign can start as early as autumn.
Also from the States, Biden administration officials said they hope to be able to distribute such calls after the summer, particularly to the elderly and people most at risk of serious infection and death.
WHAT PFIZER SAYS
Pfizer president and CEO Albert Bourla's prediction of a new vaccine ready in March 2022 has been postponed to autumn. On April 13, in fact, during a press conference of the International Federation of Pharmaceutical Companies and Associations (Ifpma) which brought together the CEOs of some of the most important Big Pharma, he said: "I hope that by the autumn we will have a vaccine for the changed variants. I know that Moderna is also working on it, we are testing different vaccines, dosages, in short, we are experimenting with many paths ”.
Another goal of the US pharmaceutical company is to obtain more lasting protection from the new vaccine: “According to Pfizer – added Bourla – a vaccine that lasts one year would be the optimal solution. It is very difficult with this virus, but we are working on it ”.
THE PFIZER TRIAL
The trial for the new vaccine, Pfizer says , will involve 1,420 volunteers aged between 18 and 55: 615 people who received two doses of the current Pfizer vaccine 3-6 months ago will receive one or two doses of the updated one; 600 who, on the other hand, have already been given three doses 3-6 months ago will receive a fourth of the current vaccine or the new version; and finally, 205 unvaccinated volunteers will be given three doses of the anti Omicron vaccine.
The full results of the study, however, will take several months as volunteers will be given multiple doses and researchers will need to measure how long the antibodies remain at a high level.
AND MODERN?
As for the competitor Moderna, the multinational is not only studying an updated version of its vaccine, but is also pursuing the search for a unique vaccine for Covid and influenza, and for a “trivalent” Covid-influenza-syncytial virus.
Meanwhile, in mid-April, it released clinical data showing that its new Covid vaccine produced a stronger immune response against major variants of the virus, including Omicron and Delta, than what is currently licensed.
THE FIRST RESULTS
According to initial results, a 50 microgram dose of Moderna's new vaccine doubled antibodies against Omicron six months after the injection compared to the original booster with the same dosage, according to Cnbc .
The clinical study so far has included 895 participants who have received a single updated dose at a strength of 50 micrograms or 100 micrograms.
EVEN CHINA DOESN'T STAY WATCHING
The Chinese pharmaceutical company Sinopharm, as reported by Global Times , has also started testing the first inactivated virus vaccine specific for the Omicron variant.
The first dose for the clinical trial was inoculated in Hangzhou, at a time when the variant, in addition to being highly transmissible, is holding the Shanghai population hostage with the risk that the restrictions will also extend to Beijing.
BECAUSE IT MAKES SENSE TO THINK OF AN UPDATED VERSION OF VACCINES
"We must have confidence in current vaccines, which still protect very well against serious disease, and hope for research to produce updated doses and increasingly effective drugs for the autumn," Palù explained.
However, he recalled that "reinfections are yet another proof that it makes no sense to talk about herd immunity" because, according to the virologist, "Sars-Cov-2 will stay with us for a long time with a seasonal trend, so a October will come back strong ".
Furthermore, according to the virologist, “we cannot exclude that Omicron mutates into a very different and more pathogenic variant, but it would be a process contrary to the evolutionary fate of the virus which has so far lost its virulence and no longer infects the lungs”.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/a-che-punto-sono-i-vaccini-anti-omicron/ on Mon, 09 May 2022 10:07:26 +0000.