The 13-valent vaccine (PCV13) also did not change the colonization of pneumococcus. Colonization of vaccine serotypes decreased, while colonization of non-vaccine serotypes increased by 12% per year.
The level of colonization among PCV13 vaccinated and unvaccinated children did not differ.
Colonization with PCV13 strains was 70% lower among healthy vaccinated children, but not among children with ARI.
In a confidential report that Pfizer provided to the European Medicines Agency, among other things, it is reported that:
1) In the first half of 2011, 22 deaths were recorded after the PCV13 vaccine. In the vast majority of cases, death occurred shortly after vaccination.
2) In two years (7/2009-7/2011), 1691 cases of adverse events were recorded, of which 18% were neurological. Among children who received only Prevenar-13, 9% of the adverse events were neurological. Among those who received Prevenar-13 along with another vaccine, 21% of the adverse events were neurological. Among those who received Prevenar-13 with Infanrix Hexa, 34% of the adverse events were neurological.
Another confidential report that Wyeth (subsequently Pfizer) provided to the European Medicines Agency which analyzes the clinical trials of the 13-valent vaccine reports:
1) Prevenar 13 clinical safety studies included 1,365 children. Of these, 493 infants and 287 children received the tested vaccine. Only 580 of them were observed for 6 months after vaccination. A 7-valent vaccine was used as a placebo.
2) Among those who received the vaccine subcutaneously, fewer than 8% used antipyretics after vaccination. Among those who received the vaccine intramuscularly, antipyretics were used by 80%.
Loss of appetite was observed in fewer than 19% in the subcutaneous group, and in more than 54% in the intramuscular group.
Irritability: less than 37% in the subcutaneous group, and more than 88% in the intramuscular group.
Drowsiness: fewer than 41% in the subcutaneous group, and more than 70% in the intramuscular group.
Sleep disturbance: fewer than 24% in the subcutaneous group, and more than 45% in the intramuscular group.
However, the manufacturer recommends that this vaccine be administered intramuscularly.
3) Adverse reactions that were reported spontaneously were reported in 83%-92%.
4) In one study, serious adverse events were observed in 11.4% of children. Most of them had infections requiring hospitalization. All of them were rated as unrelated to the vaccine. The vast majority of serious adverse reactions were among infants.
5) In total, in the group receiving the 13-valent vaccine, 35 serious complications were recorded in 25 children (out of 780). That is, the total percentage of serious complications in two studies was 3.2%. The percentage of complications from pneumococcus itself is much lower.
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