The vaccine batches used in the preclinical tests and clinical studies published in the Lancet do not have the same characteristics and properties as the vaccine batches imported into Slovakia. According to published reports, Sputnik V should be used in about 40 countries around the world, but these vaccines are only associated with the name. The comparability and consistency of different batches produced at different locations has not been demonstrated. In several cases, they appear to be vaccines with different properties (lyophilisate versus solution, single-dose ampoules versus multi-dose vials, different storage conditions, composition and method of manufacture).
The assessment of quality, efficacy and safety is always performed separately for a specific vaccine in a specific pharmaceutical form and composition. Therefore, information on the use of Sputnik V in other countries cannot be applied to batches of vaccine imported into Slovakia.
Thus, one of the hypotheses linking the vaccine to the occurrence of severe thrombosis could be an accidental intravenous injection which, in the presence of factors not fully identified, would generate a discordant immune reaction with activation of the platelets, potentially associated with a NET effect or with a decrease in the level of ACE2 on the surface of endothelial cells, leading to an increased risk of thrombosis. A simple way to overcome this hypothetical accidental intravascular injection could be to verify the absence of blood return during vaccination, which is not currently recommended by the [French] Ministry of Health
Original excerpt In French:
Ainsi, l’une des hypothèses liant le vaccin à la survenue de thrombose grave pourrait être une injection intraveineuse accidentelle qui, en présence de facteurs non intégralement identifiés, engendrerait une réaction immunitaire discordante avec activation des plaquettes, potentiellement associé à un effet NET ou à une diminution du taux d’ACE2 à la surface des cellules endothéliales, conduisant à un sur-risque thrombotique.
Un moyen simple de pallier cette hypothétique injection intravasculaire accidentelle pourrait être de vérifier l’absence de retour sanguin lors de la vaccination, ce que ne recommande actuellement pas le ministère de la santé
From a technically detailed report by “Du côté de la science” (On the side of science) – In French
In a survey of 77 epidemiologists from 28 countries, carried out by The People’s Vaccine Alliance, two-thirds thought that we had a year or less before the virus mutates to the extent that the majority of first-generation vaccines are rendered ineffective and new or modified vaccines are required. Of those surveyed, almost a third gave a timeframe of nine months or less. Fewer than one in eight said they believed that mutations would never render the current vaccines ineffective.
The overwhelming majority —88 percent— said that persistent low vaccine coverage in many countries would make it more likely for vaccine resistant mutations to appear.
“Usually one does not need to aspirate before injecting a vaccine. However, in the context of investigating a possible association between injection of covid-19 vaccine from AstraZeneca and the occurrence of rare but severe cases of blood clots and bleeding, SSI recommends, for the time being, on a precautionary principle, to aspirate before administration. This applies to all the approved covid-19 vaccines, both for injection into the deltoid muscle, but also for the alternative option of injection into the vastus lateralis muscle, if injection into the deltoid muscle is not possible.”
After problems with blood clots: Statens Serum Institut recommends new vaccine technology
Several Danish doctors have expressed concern that a widespread technique may have been one of the reasons why several people around Europe have developed fatal blood clots after being injected with the corona vaccine from AstraZeneca.
Corona vaccines must be injected into the muscle, intramuscularly as it is called. And to make sure that the needle has not hit a blood vessel instead, it is now recommended that you pull the plunger back a little to see if blood is included. If this happens, you must insert again before injecting the vaccine.
Usually it is not necessary to withdraw the plunger to give a vaccine, writes SSI, but so far it is the newly recommended method. The Danish Health and Medicines Authority has long recommended the same method.
President Miloš Zeman is calling for the county’s health minister and state drug agency director to be removed from office for rejecting the use of the Russian coronavirus vaccine Sputnik V, which has not yet received EU approval. In an interview on Wednesday, the Czech head of state also advocated not waiting for Brussels to act before using the Chinese vaccine Sinopharm.
“Between Sept 7 and Nov 24, 2020, 21 977 adults were randomly assigned to the vaccine group (n=16 501) or the placebo group (n=5476). 19 866 received two doses of vaccine or placebo and were included in the primary outcome analysis. From 21 days after the first dose of vaccine (the day of dose 2), 16 (0·1%) of 14 964 participants in the vaccine group and 62 (1·3%) of 4902 in the placebo group were confirmed to have COVID-19; vaccine efficacy was 91·6% (95% CI 85·6–95·2). Most reported adverse events were grade 1 (7485 [94·0%] of 7966 total events). 45 (0·3%) of 16 427 participants in the vaccine group and 23 (0·4%) of 5435 participants in the placebo group had serious adverse events; none were considered associated with vaccination, with confirmation from the independent data monitoring committee. Four deaths were reported during the study (three [<0·1%] of 16 427 participants in the vaccine group and one [<0·1%] of 5435 participants in the placebo group), none of which were considered related to the vaccine.
This interim analysis of the phase 3 trial of Gam-COVID-Vac showed 91·6% efficacy against COVID-19 and was well tolerated in a large cohort.”
The Pfizer and Moderna vaccines will be the first-ever messenger RNA (mRNA) vaccines brought to market for human patients.
When Moderna was just finishing its Phase I trial, The Independent wrote about the vaccine and described it this way: “It uses a sequence of genetic RNA material produced in a lab that, when injected into your body, must invade your cells and hijack your cells’ protein-making machinery called ribosomes to produce the viral components that subsequently train your immune system to fight the virus.”
“In this case, Moderna’s mRNA-1273 is programmed to make your cells produce the coronavirus’ infamous coronavirus spike protein that gives the virus its crown-like appearance (corona is crown in Latin) for which it is named,” wrote The Independent.
Oxford University’s AstraZeneca, the Russian’s Sputnik V and the Israel Institute for Biological Research’s Brilife are all based on more traditional technologies