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A Sinopharm vaccine
Sinopharm is a vaccine made using traditional technology that contains an inactivated virus.
According to information from OGYÉI, the vaccine is prepared using the 19nCoV-CDC-Tan-HB02 strain, on Vero cells, and then, after incubation, the liquid is recovered, inactivated, concentrated, purified and Al (OH) 3 adjuvant (enhancer). ) are added.
The BBIBP-CorV vaccine has so far been licensed in 14 countries, in addition to Hungary, in Bahrain, Cambodia, China, Egypt, Iraq, Jordan, Morocco, Nepal, Pakistan, Peru, Serbia, Seychelles, and the United Arab Emirates.
Three-phase clinical trials are currently underway, with Bahrain, Egypt, Jordan and the United Arab Emirates participating in the largest trial of 45,000 people. Phase 1/2 tests were conducted in China; however, due to the small number of infected, China was not suitable to initiate large sample tests, as a region is needed to determine efficacy where there is an epidemic, thus exposing study participants to infection. The first clinical trial is a phase 1/2 randomized, double-blind, placebo-controlled study in China, initially evaluating the safety and immunogenicity of the product in adults 18 years of age and older. The second is one an international, multicenter, randomized, double-blind, placebo-controlled phase III clinical trial evaluating the protective efficacy, safety, and immunogenicity of the product.
This drug has been conditionally approved based on data from phase III clinical trials. Final data are not yet available for evaluation of protective effect, efficacy and safety still need to be further verified; it can be read in the OGYÉI leaflet.
So far, 550,000 doses of the Sinopharm vaccine have reached Hungary, which is enough to vaccinate 275,000 people.
The total consolidated quantity is 5 million doses, enough for 2.5 million people. Sinopharm has no age restrictions and can be used in chronic patients.
Side effects of the coronavirus vaccine
The subjects were closely monitored for sudden reactions for 30 minutes after each injection. Systemic (systemic) and injection site adverse reactions were recorded in a log for 7 consecutive days after each injection. Subjects were closely monitored for adverse events from unorganized data collection for 28 days, hospital emergency department visits, unexpected doctor’s office visits, and serious adverse events for 12 months. Information on adverse reactions from unorganized data collection was collected by telephone interview or intermediate clinic visit. Among the systemic (systemic) side effects at the injection site most commonly reported in adults 18 years of age and older from organized data collection 7 days after injection the side effect experienced was pain at the injection site. Fever, fatigue, headache, and diarrhea were also common.
The classification of adverse reactions is that recommended by the Council of International Medical Organizations (CIOMS). Frequency of side effects:
- very common (≥10%)
- common (≥1%,
- uncommon (≥0.1%,
- rare (≥0.01%,
- very rare (
Side effects at the injection site:
- very frequent: pain
- infrequent: warmth, swelling, hardening or lumps of the skin, rash, itching
- weird: redness of the skin
Systemic side effects
- very frequent: frequent headaches: fever, fatigue, muscle pain, joint pain, cough, shortness of breath, nausea, diarrhea, itching
- infrequent: dizziness, loss of appetite, vomiting, pharyngeal pain, difficulty swallowing, runny nose, constipation, hypersensitivity
- weird: sudden allergic reaction (acute, acute), drowsiness, insomnia, sneezing, pharyngitis, nasal congestion, dry throat, flu-like symptoms, decreased sensation, pain in extremities, palpitations, abdominal pain, skin rash, rash , skin rash, skin mucus, skin mucus, skin mucus in the ear, lymph node disease (lymphadenopathy)
- very rare: chills, taste disturbances, loss of taste, sensory disturbance (paresthesia), tremor, attention deficit, asthma, throat irritation, tonsillitis, limb discomfort, neck pain, jaw pain, neck pain, neck swelling , mouth ulcer, toothache, swallowing, discoloration when swallowing, eye pain, blurred vision, eye irritation, loss of vision, ear pain, nervousness, high blood pressure, low blood pressure, difficulty urinating (incontinence urinary), delayed menstrual bleeding.
In clinical trials, mainly mild reactions occurred, In the 18-59 age group, some type of injection site side effect was seen in 19.5 percent of those vaccinated with the vaccine in studies outside of China. Interestingly, a higher proportion of placebo recipients reported a local effect in the young age group, 27.5 percent. Overall, a lower proportion of local adverse events were reported in clinical trial participants older than 60 years, but they also had a higher rate of adverse events in placebo recipients than vaccine recipients (19 percent vs. 11.6 percent).
Systemic adverse events were reported in a similar proportion of those who received the vaccine and the placebo in the group aged 18 to 59 years (22.9 percent and 22.4 percent, respectively), and slightly higher in the group older (22.3 percent of those who received the vaccine). placebo recipients). There was a greater difference in the side effects of headache and fever between those who received the vaccine and the placebo in the older group (it was significantly greater than those vaccinated).
Grade 3 side effects at the injection site include: pain, rash, itching; and Grade 3 systemic (systemic) side effects include fever, fatigue, headache, muscle aches, joint pain, cough, shortness of breath, vomiting, diarrhea, constipation, difficulty swallowing. Grade 4 side effects have not yet been reported with this drug, according to the OGYÉI package insert.
The out-of-China phase was experienced in three clinical trials serious side effects of a topic before October 31, 2020 severe nausea and vomiting experienced that he recovered after the medication. In the researcher’s opinion, this is related to the use of the product. Another issue after the administration. his right arm was weak and he spoke silently. He was examined at the local hospital to rule out inflammatory demyelinating syndrome, multiple sclerosis (MS), clinically isolated syndrome (CIS), and acute disseminated encephalomyelitis (ADEM). No association has been established between the use of the product and this case.
It doesn’t hurt to have side effects
One of the main arguments of those who fear vaccination against coronavirus is that they are concerned about side effects, but it should be noted that complications can occur with any vaccination. In clinical trials of coronavirus vaccines approved to date, adverse reactions have typically occurred as with any other vaccine, and very few serious reactions have been reported. The long-term effects, and how long the currently licensed vaccines may be effective, are not yet known, as developments began less than a year ago. What we know so far is that experience has shown that after the second vaccination, side effects are more common, which, while unpleasant, also indicate that the immune system is responding and protection is beginning to develop. Serious side effects have been rare compared to what the disease can cause (such as problems lasting up to months, even in healthy young adults), so it seems a better decision to go through side effects that last a few days than to take risks .
The side effects of other vaccines used in Hungary and their frequency are described in detail in the following articles:
Coronavirus vaccine registration
Vaccines against the coronavirus were launched in Hungary in December, which is free and voluntary in Hungary, so all people who want to get vaccinated must be notified. The coronavirus vaccine registry is available continuously. To register, you must provide a name, address, contact information, age, and TAJ number.
Those who register at vakcinainfo.gov.hu will be notified at the contact details provided when appropriate in accordance with the vaccination plan. In Hungary, the vaccination campaign started with health workers, followed by social assistance workers and social assistance recipients. Vaccination of the older age group has already started and thanks to the arrival of the AstraZeneca vaccine, vaccination of chronic patients under 60 years of age has also started.
Cover image: Raul Sifuentes / Getty Images
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