The president of the United States, Joe Biden, is about to give a bad blow to Pfizer, Moderna and Johnson & Johnson, the three American companies that together with AstraZeneca have the domain of vaccinations against Covid. In fact, within a few hours it will announce the change of position of the United States on the protection of vaccine patents and the intention to suspend the intellectual property of those companies in order to allow the whole world to mass produce those vaccines. The first step came yesterday from the Biden administration representative within the WTO, the world trade organization. In fact, Katherine Tai announced that “The administration firmly believes in intellectual property protections but to put an end to this pandemic it supports the revocation of certain protections for Covid-19 vaccines”. The formalization of the American position did not at the moment cause a jolt on Wall Street, where the shares concerned remained stunned for a few minutes, also because for the actual suspension a broad agreement within the WTO itself is needed. But what pushed this step was the international pressure for the disastrous situation of Covid in India and also the growing awareness of the uselessness of mass vaccinations in richer countries if the virus then circulates freely in the poorer ones, which inevitably then they would export it.
While this veritable bomb arrives on the vaccine market from the United States, Mario Draghi’s Italy takes a very risky step that would seem to go in the opposite direction: at the request of the Scientific Technical Committee, the time that passes between the first is about to double. and the second administered dose of Pfizer and Moderna vaccines. The weather forecast today (21 days for Pfizer and 27 for Moderna) is about to be extended to 42 days, with a choice that somehow echoes the risk Boris Johnson took in Great Britain with AstraZeneca. The reason is the same as the English one: despite the many efforts made and some obviously risky promises, the pace of vaccinations in Italy has grown less than what was expected. The achievement of 500 thousand doses was only achieved for two days at the end of April, then we went down again and not by a small amount. The feeling is that between supplies in fits and starts and the difficulty of keeping 19 Regions and 2 autonomous provinces at the reins, the government is aiming to increase the number of vaccinated people with the first dose to the detriment of those with both doses.
On the other hand, the push that Johnson & Johnson could have given thanks to its single-dose has also failed and we wanted to somehow run for cover. To do this, Italy relies on the invitation received on 21 January from the World Health Organization, which explained: “There are currently no data on the long-term efficacy for a single dose of the Mrna Pfizer-BioNTech vaccine, since the participants the study received 2 doses with a dose interval in the study ranging from 19 to 42 days. Of note, neutralizing antibody responses are modest after the first dose and substantially increase after the second dose. Countries experiencing exceptional epidemiological circumstances may consider delaying the administration of the second dose for a short time as a pragmatic approach to maximize the number of individuals benefiting from a first dose while vaccine supply continues to increase. The WHO recommendation at present is that the dosing interval can be extended up to 42 days (6 weeks), based on currently available clinical trial data (…) Countries should ensure that any program adjustments of this type at the dose intervals do not affect the probability of receiving the second dose “.
But that of the WHO was a choice thought globally and based on the difficulty of supplying vaccines. Not exactly shared by scientists, because in reality no clinical studies have been published on the effects of a second dose administered after 42 days instead of the 21 or 27 recommended and in the experimentation of the various phases of the vaccine there are very few cases in which the second dose has been administered with such a delay: so small (about 1%) that no in-depth analysis has been published.
On the other hand, this decision certainly entails a risk, and it is that of fragile patients for whom vaccination could provide even lower coverage than the current one. The CTS in fact mentions an 80% immunization starting two weeks after the first dose of Pfizer and Moderna, but this is only true for patients who do not have serious comorbidities. For cancer patients, for example, the coverage ascertained by studies already published is around 51% with the first dose and around 72% after the second. Moving it another two weeks would put them at great risk. A study carried out by King’s College of London on the efficacy of the Pfizer vaccine on cancer patients was published in Lancet on 27 April. And the result was disappointing: «In patients with cancer, one dose of the vaccine produces poor efficacy. Immunogenicity increased significantly in solid cancer patients within 2 weeks of a vaccine boost on day 21 after the first dose. These data support the prioritization of cancer patients for an early second dose (day 21) of the Pfizer vaccine. ‘ The same result is offering a much more extensive study in the sample that is taking place in Rome. The decision of the CTS must immediately exclude all fragile patients.