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04-26-2024     3 رجب 1440

Covid-19 Vaccine: Bypass to a Long Road-11

November 25, 2020 | Umar Bin Abdul Aziz

Operation Warp Speed


Operation Warp Speed founded on 15 may 2020 is a public–private partnership, initiated by the U.S. government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. Their goal is to bring 300 million doses of a safe and effective vaccine to the general public by January 2021. In order to achieve this, OWS is providing government support to the most promising vaccine candidates and steps in the traditional development timelines are occurring simultaneously.
Fourteen (14) potential vaccines have been selected from over 100 contenders currently in development. Leading the pack (as of November 5, 2020), are Moderna’s mRNA-1273 vaccine undergoing phase 3 trials and Pfizer and BioNTech’s BNT162b2 vaccine in a combined phase 2-phase 3 trial. Both vaccines utilize messenger RNA (mRNA) to carry genetic material that codes for viral proteins to the cell. Once inside the cell, mRNA instructs the cell to make copies of that protein, stimulating the immune system to respond. These vaccines can be produced rapidly and efficiently.
Many candidate vaccines will not make it through the rigorous clinical development process. Even if one vaccine completes these stages in record speed, our fight against COVID-19 remains an uphill battle. The coronavirus vaccine has to have an efficacy of at least 70% to prevent an epidemic and at least 80% to extinguish an epidemic without any other measures (i.e. physical distancing).
A vaccine will certainly get us one step closer to normalcy but only if it is proven safe and effective and achieves widespread acceptance. It is a waiting game and like all good things, we must be patient.


Update November 9, 2020


Pfizer and BioNtech announced their vaccine candidate against COVID-19 has achieved success in its first interim analysis from their Phase III study. Their vaccine was found to be more than 90% effective in preventing COVID-19 in study participants without evidence of prior SARS-CoV-2 infection. The interim analysis included 94 confirmed cases of COVID-19 participants from over 43,000 study subjects enrolled. No serious safety concerns have been observed. Pfizer and BioNtech will submit an application for Emergency Use Authorization (EUA) to the FDA after they reach a required safety milestone. They must observe for adverse events for at least two months and that two-month mark will occur at the end of November. The clinical trial will continue through final analysis when 164 confirmed cases are evaluated.

Update November 16, 2020

Moderna, Inc., announced today that their COVID-19 vaccine mRNA-1273 was found to have an efficacy of 94.5%. The interim analysis was conducted by an independent NIH-appointed Data Safety Monitoring Board (DSMB) for their Phase 3 study. The first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group that statistically points to an estimated vaccine efficacy of 94.5%. This vaccine is part of Operation Warp Speed and by the end of 2020, Moderna expects to have 20 million doses of the vaccine ready.
Moderna’s vaccine has a key advantage over the Pfizer vaccine in that it can be stored at minus 20 degrees Celsius. The Pfizer vaccine must be stored at minus 75 degrees Celsius and provider offices and pharmacies do not have freezers that can be kept at temperatures that low. Another advantage is that Moderna’s vaccine can be stored for 30 days in the refrigerator whereas Pfizer’s vaccine can last only 5 days in the refrigerator. (Concluded)

 

Email:---Omarbarkan4u@gmail.Com

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Covid-19 Vaccine: Bypass to a Long Road-11

November 25, 2020 | Umar Bin Abdul Aziz

Operation Warp Speed


Operation Warp Speed founded on 15 may 2020 is a public–private partnership, initiated by the U.S. government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. Their goal is to bring 300 million doses of a safe and effective vaccine to the general public by January 2021. In order to achieve this, OWS is providing government support to the most promising vaccine candidates and steps in the traditional development timelines are occurring simultaneously.
Fourteen (14) potential vaccines have been selected from over 100 contenders currently in development. Leading the pack (as of November 5, 2020), are Moderna’s mRNA-1273 vaccine undergoing phase 3 trials and Pfizer and BioNTech’s BNT162b2 vaccine in a combined phase 2-phase 3 trial. Both vaccines utilize messenger RNA (mRNA) to carry genetic material that codes for viral proteins to the cell. Once inside the cell, mRNA instructs the cell to make copies of that protein, stimulating the immune system to respond. These vaccines can be produced rapidly and efficiently.
Many candidate vaccines will not make it through the rigorous clinical development process. Even if one vaccine completes these stages in record speed, our fight against COVID-19 remains an uphill battle. The coronavirus vaccine has to have an efficacy of at least 70% to prevent an epidemic and at least 80% to extinguish an epidemic without any other measures (i.e. physical distancing).
A vaccine will certainly get us one step closer to normalcy but only if it is proven safe and effective and achieves widespread acceptance. It is a waiting game and like all good things, we must be patient.


Update November 9, 2020


Pfizer and BioNtech announced their vaccine candidate against COVID-19 has achieved success in its first interim analysis from their Phase III study. Their vaccine was found to be more than 90% effective in preventing COVID-19 in study participants without evidence of prior SARS-CoV-2 infection. The interim analysis included 94 confirmed cases of COVID-19 participants from over 43,000 study subjects enrolled. No serious safety concerns have been observed. Pfizer and BioNtech will submit an application for Emergency Use Authorization (EUA) to the FDA after they reach a required safety milestone. They must observe for adverse events for at least two months and that two-month mark will occur at the end of November. The clinical trial will continue through final analysis when 164 confirmed cases are evaluated.

Update November 16, 2020

Moderna, Inc., announced today that their COVID-19 vaccine mRNA-1273 was found to have an efficacy of 94.5%. The interim analysis was conducted by an independent NIH-appointed Data Safety Monitoring Board (DSMB) for their Phase 3 study. The first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group that statistically points to an estimated vaccine efficacy of 94.5%. This vaccine is part of Operation Warp Speed and by the end of 2020, Moderna expects to have 20 million doses of the vaccine ready.
Moderna’s vaccine has a key advantage over the Pfizer vaccine in that it can be stored at minus 20 degrees Celsius. The Pfizer vaccine must be stored at minus 75 degrees Celsius and provider offices and pharmacies do not have freezers that can be kept at temperatures that low. Another advantage is that Moderna’s vaccine can be stored for 30 days in the refrigerator whereas Pfizer’s vaccine can last only 5 days in the refrigerator. (Concluded)

 

Email:---Omarbarkan4u@gmail.Com


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