ABSTRACT
Introduction Data on the effectiveness and safety of new vaccines against COVID-19 in patients (pts) with hematological diseases are just beginning to accumulate. We planned to obtain such information for pts with chronic myeloid leukemia (CML) during vaccination. Objective. To evaluate the antibodies formation and adverse events (AEs) after vaccination against COVID-19 in pts with CML Materials and methods. All pts with CML diagnosis who applied to the National Research Center for Hematology (NRCH, Moscow, Russia) for outpatient or remote consultations were suggested to prospectively report the AEs after getting a vaccination against COVID-19 by the most frequently used vector-based vaccine GamCovidVac (Sputnik V). Two vaccine components with the interval of 21 days were given at the vaccination facilities, as prescribed. At least after 3 weeks after the 2 nd injection, pts were advised to perform a blood test for the specific antibodies against spike (S) protein of SARS-CoV-2. A semi-quantitative test detecting the SARS-CoV-2 S1 subunit (RBD) IgG antibodies by enzyme-linked immunoassay (ELISA) kit was used in the clinic. The results were considered positive with the cutoff index >1,1. The use of any other lab tests detecting antibodies to S protein of SARS-CoV-2 was acceptable as well. Results. In total, 66 pts with chronic phase of CML received a vaccination by Sputnik V in the 7 months period (from 18.12.2020 to 20.07.2021). Me age was 54 years (range 29 - 89 years), 34 (52%) were males. Median (Me) CML duration was 8 years (from the moment of diagnostics up to 20 years). Fifty one (77%) pt received TKI therapy and 15 (23%) were off-therapy at the time of vaccination, including 12 (18%) in a treatment-free remission and 3 (4,5%) pts in the process of diagnosis. Deep and major molecular response (MMR) was in 46 (70%) and 7 (11%) pts, respectively. Two (3%) pts had a molecular response MR2, 11 (17%) had no MR2. Eight (12%) pts had a history of COVID-19 manifestation prior to vaccination. Me time for testing for the antibodies was 27 days (range 5-77) after the 2 nd vaccine injection. The tests were done in 44 (67%) of pts and revealed positive by any of the test systems in 42 (95%) pts. ELISA test was used in 30 (45%) pts and was positive in 25 (83%) of 30 pts. Me cutoff index in the positive samples was 7,7 (range 1,1 - 12) and corresponded to the value observed in healthy people after vaccination (medical stuff, data not shown). In all 3 pts with the history COVID 19, the index of positivity was above the Me value (Fig. 1, 2). Other test systems were used in 14 (21%) pts, in all 14 (100%) the antibodies were found. In 3 of 5 patients with the cutoff index<1 the antibodies were detected by using other test systems, but all with a level slightly above the detection threshold. Me age of these 5 pts was 63 years (range 59- 70), Me time of analysis was 49 days (range 23-59) after 2 nd vaccine shot. All these pts were on treatment by tyrosine kinase inhibitors, 3 pts with MMR and deeper, 1 pt with MR2 and 1 pt without MR2. A weak reverse correlation of the antibody levels with the time after vaccination was noted ( r = - 0,39, p = 0,033). A very weak reverse correlation with age was observed ( r = - 0,28, p = 0,127) (Fig. 1, 2). No AEs after the vaccination were observed in 25 (38%) pts while 41 (62%) pts reported the AEs and 7 (10%) pts did not report their reactions. The AEs were as follows: local pain/discomfort in the injection site in 19 (29%) pts, weakness and/or drowsiness in 20 (30%), fever and/or chills in 16 (24%), other reactions in 8 (12%) including headache, heartbeat, lower back pain, pain in limbs, activation of herpes infection. Conclusion: The single center study revealed no unusual or unexpected AEs in CML pts after the vaccination against COVID-19 by Sputnik V vaccine. The proportion of CML pts with specific antibodies after was 95% which is close to the published results of the 3rd phase study. No significant correlation was found with age (r = -0,28, p = 0,127), however, the absence or very low a tibody levels were detected in individual patients aged about 60-70 years. This data raise a question of a necessity for a non-specific protection (masks, respirators, distance etc) and probably considering additional vaccination in some elderly persons. The duration of a humoral response against COVID-19, protective antibody titer and connection with clinical outcomes in CML pts need further evaluation in parallel with a common population. [Formula presented] Disclosures: Chelysheva: Pfizer: Speakers Bureau;Pharmstandart: Speakers Bureau;Bristol Myers Squibb: Speakers Bureau;Novartis Pharma: Speakers Bureau. Petrova: Pfizer: Speakers Bureau;Novartis Pharma: Speakers Bureau. Gurianova: Pfizer: Speakers Bureau. Turkina: Pharmstandart: Speakers Bureau;Pfizer: Speakers Bureau;Novartis Pharma: Speakers Bureau;Bristol Myers Squibb: Speakers Bureau.
ABSTRACT
Introduction Despite the availability of vaccination against COVID 19 for all population categories since January 2021, it is moving slowly in Russia. Patients (pts) with chronic myeloid leukemia (CML) usually lead a normal life with social interactions. In the context of the COVID 19 pandemic, we find it important to identify the factors of adherence to vaccination and clarify the concerns. Objective: To determine the proportion of CML pts willing to consider vaccination against COVID 19, adherence factors and reasons for not vaccinating. Materials and methods. A survey on the attitude to vaccination against COVID 19 was prospectively carried out among all pts with CML consulted at the outpatient department of National Research Center for Hematology (Moscow, Russia) who agreed to participate. The key questions included considerations for and against vaccination, socio-demographic and clinical characteristics, lifestyle, comorbidities and history of COVID 19. Results. Within 4 months (from March 15 to July 19, 2021), 172 CML pts completed the questionnaire. CML chronic phase, advanced phase and blast crisis were in 167 (97%), 4 (2%) and 1(1%) respectively. In total, 141 (82%) pts were on therapy with 1 st, 2 nd and >3 rd therapy line in 77 (55%), 33 (23%) and 31 (22%) pts, respectively. Thirty one (18%) had no therapy: 6 (3.5%) newly diagnozed, 25 (14.5%) in a treatment-free remission. A deep and major molecular response was in 77 (45%) and 30 (17%) pts, respectively. Presence and absence of molecular response MR2 was in 20 (12%) and 45 (26%) pts respectively. The median age of pts was 46 years (range 19-82), 75(44%) were males. Married 108 (63%), 70 (41%) lived with elderly relatives, 35 (20%) with children. A higher education was in 123 (72%) pts, 123 (72%) could not work remotely and 46 (27%) had interactions to people by work. Any comorbidity was in 89 (52%) pts, 42(24%) had >1 concomitant disease, 48 (28%) had cardiovascular diseases, 44 (26%) had an obesity. A history of COVID 19 was in 41 (24%) pts and in the close circle of 74 (43%) pts. Vaccination was supported by 94(55%) pts (with 29 (17%) already vaccinated) and not supported by 76 (44%) pts, 2 (1%) pts did not answer. Among those supporting vaccination vs not supporting there was significantly more males (52% vs 33%, p=0,012), married pts (73% vs 49%, p<0,001) and pts with higher education (88% vs 51%, p=0,006). Other factors (age, comorbidities, obesity, profession-related features, COVID 19 in pts or their environment, living with elderly relatives or children, therapy and treatment response) were not significant. Less pts were against vaccination in June-July 2021 before the 3 rd outbreak of COVID 19 compared to spring period (33% vs 50%, p=0,045). The two most common reasons to avoid vaccination were the fear of complications in 37(49%) pts and waiting for additional data in 19(25%) (Fig.1). Notably, 7 (9%) pts considered CML as a contraindication to vaccination. Among those supporting vaccination, 55(59%) preferred to choose the GamCovidVac (Sputnik V) vaccine, 20(21%) had no preference (Fig.2). Out of 32 pts who gave the rationale for the Sputnik V choice 19(59%) noted its best availability, study or popularity (Fig.3). Among 23 pts with additional questions 12 (52%) wondered about the possibility of vaccination with CML diagnosis and 6 (26%) asked help with a vaccine choice. Conclusion: Despite access to vaccines against COVID 19 with proven efficacy and safety, almost half of CML pts (44%) do not support vaccination. Socio-demographic factors such as gender, education, marriage status appeared to be significant for this decision. Considering the frequent concerns of the possibility of vaccination with CML diagnosis as well as the fear of complications, hematologists should provide a relevant clarifying information on these issues. [Formula presented] Disclosures: Chelysheva: Pfizer: Speakers Bureau;Novartis Pharma: Speakers Bureau;Pharmstandart: Speakers Bureau;Bristol Myers Squibb: Speakers Bureau. Petrova: Pfizer: Speakers Bureau;Novartis Pharma: Speakers Bureau. Gurianova: Pfizer: Speakers Bureau. Kokhno: Novartis Pharma: Speakers Bureau;Bristol Myers Squibb: Speakers Bureau. Turkina: Novartis Pharma: Speakers Bureau;Pfizer: Speakers Bureau;Pharmstandart: Speakers Bureau;Bristol Myers Squibb: Speakers Bureau.
ABSTRACT
Background: Due to the challenge of COVID-19 pandemic the prognosis for patients (pts) with hematologic (hem) tumors, including chronic myeloid leukemia (CML), was difficult to make. With the data accumulation and vaccination start in early2021, a view of the problem begins to change. Aims: We aimed to describe the disease course of COVID-19, treatment and first vaccination data in pts with CML in Russian Federation. Methods: A total of113 CML pts were analyzed:106 pts with lab-confirmed or suspected COVID-19 and 7 pts vaccinated against COVID-19. Registration of COVID-19 cases was done prospectively during in person or remote consultations from March2020 till February2021. The pts were participants of CHRONOS19, a nationwide observational cohort study of adult (≥18 y) pts with wide spectrum of hem diseases (NCT04422470). We performed a sub-analysis for CML and COVID-19 cohort with the data of 3 hem clinics regarding diagnostics, disease course, treatment and outcomes. Additionally, we evaluated the tolerability and first vaccination results in 7 CML pts (Sputnik V in civil vaccination). Results: Case registration corresponded to incidence in the country with clear2 "waves":1st one in March-August (n=35) and2nd starting from September2020 (n=71) (fig1). COVID-19 was clinically and/or lab diagnosed and treated according to current national recommendations. CML was newly diagnosed during COVID-19 in 8(8%) pts, while 86(81%) were on treatment and12(11%) were in treatment-free remission (TFR). One case was in pregnant pt. CML phases were chronic(CP)/accelerated/blast crisis in 95(89,6%), 6(5,4%) and 5(5%) pts respectively. Median (Me) age of pts was 52 years (range22-75), 58(55%) were male. No CML therapy during COVID-19 was in 34 (32%) pts (interrupted or not started), therapy was held in 67 (63%), no data in 5 (5%). Disease course of COVID-19 was asymptomatic, mild, moderate and severe in 5 (5%), 59 (56%),29(27%) and13(12%) pts respectively. No therapy for COVID-19 was in 30 (28%) pts, symptomatic therapy (fever relief, anti-cough, decongestants, vitamins etc) - in 73 (69%) pts, antiviral drugs and antibiotics were used in28 (26%) and 44 (42%) pts respectively. Anticoagulants, corticosteroids and IL-6 inhibitors were introduced mainly during2nd wave while hydroxychloroquine was abandoned (fig.1). Hospitalization was in 33(31%) pts, oxygenation was applied in12 (11%) pts. The outcomes were as follows:101(95%) pts alive (98 recovered, 3 not yet), 4 (3,7%) pts died (2 due to COVID,2 to CML progression),1(1,3%) -no data. No COVID reinfection was detected so far. No factors connected with moderate/severe vs asymptomatic/ mild COVID-19 were found when analyzing gender, CML phase, TFR, comorbidities,1st and2nd wave, except age≥52 years (p=0,039). A trend of mild disease was in pts taking TKI vs without TKI (p=0,065). Seven CP CML pts with Me age 63 years (range 50-70) were vaccinated against COVID-19 since December2020:2 had the1st shot and 5 pts completed vaccination. All 7 pts tolerated the procedure well, with no adverse effects. One pt was checked for antibodies21 days after the2nd shot and revealed a high level of anti-SARS-CoV-2 IgG with coefficient of positivity 6,2 (reference range 0-0,9). Summary/Conclusion: The incidence, disease course and COVID-19 dependent mortality rates in CML pts seem to be similar to common population. Older age is a factor of moderate/severe disease course. The TKI impact on COVID-19 course and post-vaccination immunity in CML pts need to be studied.