COVID Vaccines, what’s new: an update on the latest clinical trials that are underway with the currently administered vaccines
The global pandemic posed a challenge for the launch of safe and effective vaccines with a lighting speed. Pharma companies have quickly developed the vaccines and regulatory agencies have assessed with emergency approvals. In the second year of this pandemic, as the vaccination process is ongoing and with the ‘relaxing’ of rules in certain states, in this blog we tried to shed some light on the next steps and updates associated with the vaccines, especially in the context of clinical trials.
COVID19 vaccines currently administered in the US are based on mRNA and viral vector technologies. Both vaccines contain the genetic material of SARS-CoV-2 spike protein. Once injected, it produces a large number of spike proteins which primes the immune system to fight against the viral infection. The two major mRNA vaccines available in the US are from Pfizer/ BioNtech and Moderna.
Pfizer vaccine:
• Pfizer-BioNtech BNT162 vaccine, the first company to get emergency FDA approval, is now aiming for single-dose immunogenicity assessment in adults.
NCT04824638• Lower strength 2 dose trial in children aged 6 months to 11 years was initiated. Vaccination in children has started with the recent emergency approval. NCT04816643
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• Trial in healthy pregnant women to test immunogenicity of 2 doses 21 days apart has also started
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Moderna vaccine:
• Moderna started testing against the B.1.351 variant and is investigating booster doses on previously vaccinated adults. NCT04785144 NCT04405076 (Ref)
• Moderna developed a new version of mRNA-1283 vaccine and testing it to be potentially refrigerator-stable so as to overcome distribution hassles.
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• Immunogenicity of the vaccine in patients with solid tumors who are on PD1/PDL1 inhibitor therapy is being studied.
NCT04847050• Dose evaluation study in children aged 6 months to less than 12 years is also ongoing.
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AstraZeneca vaccine:
• The major vaccine player in Europe, extended trials in other countries including the US as they wait for FDA’s approval (
Ref)
• New version of AZ’s vaccine which can be intranasally delivered is under trial
NCT04816019• One study is testing the vaccine’s efficacy in patients with liver cirrhosis
NCT04794946• A combination study of AZD1222 with rAd26-S vaccine is underway to test as heterologous prime boost regimen.
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Johnson and Johnson vaccine:
• The single dose of Ad26.COV2.S adenovirus vector vaccination that was stopped due to certain adverse events was recently allowed to be resumed. (Ref)
• JnJ is extending trials outside the US by testing its effectiveness in health care workers in South Africa.
NCT04838795• The vaccine is been tested in healthy pregnant women administrating 2 doses, 57 days apart.
NCT04765384• Two-dose efficacy of the vaccine in healthy participants is also ongoing.
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Gamaleya Research Institute – Russian Sputnik vaccine
• After successful 2 dose vaccination in Russia, now they have initiated to test single dose in healthy participants
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Sinovac vaccine
• Recently started CoronaVac immunogenicity study in autoimmune rheumatic diseases and HIV/AIDS patients in Brazil.
NCT04754698• In another trail in urban Brazil, a 2-dose study is initiated, administering with an interval of 4 weeks.
NCT04747821• A phase 3 study in Turkey is initiated to test effectiveness in healthy women.
NCT04751721• Another study is initiated in healthy children and adolescents aged 3-17 years.
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Comparative trials are critical in evaluating the safety and efficacy by directly comparing the vaccines in trials. AstraZeneca, Pfizer, Moderna and Sputinik vaccines are underway in such trials.
• In one study Pfizer and Moderna vaccines are tested to estimate their systemic allergic reactions. NCT04761822
• Another Moderna, Pfizer comparative study initiated in Swiss, assess the comparative effectiveness and safety in immunocompromised patients
NCT04805125• In Hongkong, a comparative reactogenicity and immunogenicity with BNT162b2, CoronaVac and AZD1222 in young adolescents.
NCT04800133• A combination of Regeneron’s antibody cocktail, Casirivimab + Imdevimab with Moderna mRNA-1273 vaccine is administered in healthy adult volunteers to study immunogenicity and tolerability.
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Almost all the vaccines are doing well with good efficacy, but the question is, does the built immunity last long against the SARS-CoV-2 virus and does it protect us from all the different variants? We will have to wait and watch how these vaccines progress in upcoming trials and various vaccinations programs.
Major COVID19 vaccine details
