Safety, tolerability, and antibody response after intradermal vaccination of PFE-BNT in adults who have completed two-doses of Verocell (inactivated vaccine)

Abstract

IntroductionThe necessity for an equal distribution of the COVID-19 vaccination is critical. Lower-middle and lower income countries may not be able to manufacture their vaccines, nor may they be able to afford to buy them for every inhabitant. Furthermore, the vaccination's potency may wane over time. A booster dosage is recommended. Despite this, certain areas or groups of people are still waiting for their first vaccine dosage. ObjectivesThe purposes of this study were to assess the safety and tolerability of patients who received a fractionated intradermal administration (ID) of PFE-BNT as a booster dose in a group of people who had previously finished full doses of Verocell and to determine the antibody response after the injection. MethodsAn open-label experiment was carried out. Participants were at least 18 years old. Participants received 6 ug of PFE-BNT vaccination through intradermal injection. The safety and adverse reactions were monitored at immediate after injection, 30 min later, day 1, day 7, and day 30. Venous blood tests for specific IgG concentration against SARS-CoV-2 spike S1 were received prior to injection and day 30. Results42 participants completed the study. The mean age was 48 (the range; 23–62). The average duration after completing the 2nd dose of Verocell was 78.3 days (95% CI; 73.9–82.8). There was no serious adverse event. Almost 50% of participants reported minor adverse reactions on day 1 and roughly 30% still reporting on day 7. Systemic reactions were found less than 5%. The antibody level at day 30 was 16669.8 (95% CI; 3692.6–51238.9), which was 40 times higher. ConclusionPFE-BNT at a dose of 6 ug (1/5 of the typical dose) was shown to be safe and well tolerated when given intradermally. The antibody reaction was very strong. The ID administration could potentially save vaccine doses.