코로나19 백신 정리
20년 11월 20일자 뉴스 정리.
Pfizer-BioNTech
The Pfizer-BioNTech COVID-19 vaccine was sent to the FDA for possible Emergency Use Authorization (EUA) on Friday, November 20. It is an mRNA vaccine that codes for the virus’s spike protein and is encapsulated in a lipid nanoparticle. Once injected, the cells churn out the spike protein, triggering the body’s immune system to recognize the virus. In Phase III trials, it demonstrated 95% efficacy. The Pfizer-BioNTech vaccine requires storage at about -94 degrees F, which requires specialized freezers.
Type: mRNA
Doses: 2, 28 Days Apart
Likely EUA Date: December 10, 2020
Doses by Year End: ~50 Million
Price: $19.50 per dose for first 100 million doses
Moderna
On November 16, Moderna issued a preliminary data readout out of its COVID-19 vaccine, suggesting an efficacy rate of 94.5%. Like the Pfizer-BioNTech vaccine, it is an mRNA vaccine. Unlike that vaccine, however, the Moderna vaccine is stable at 36 to 46 degrees F, about the temperature of a standard home or medical refrigerator, for up to 30 days and can be stored for up to six months at -4 degrees F. It is expected to go to the FDA for consideration for an EUA within days.
Type: mRNA
Doses: 2, 28 Days Apart
Likely EUA Date: December 10, 2020
Doses by Year End: 50 Million
Price: $25-$37 per dose
AstraZeneca-University of Oxford
On November 23, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The analysis was from the trials in the UK and Brazil and demonstrated efficacy of up to 90%. The vaccine was effective at preventing COVID-19, with no hospitalizations or severe cases in people receiving it. There were a total of 131 COVID-19 positive cases in the interim analysis group. One dosing regimen was given at a half dose and demonstrated 90% efficacy, followed by a full dose at least one month apart. Another dosing regimen demonstrated 62% efficacy when given two full doses at least one month apart. The combined analysis showed average efficacy of 70%. The AstraZeneca vaccine can be stored, transported and handled at normal refrigerated conditions, about 36-46 degrees F, for at least six months and administered within existing healthcare settings.
AstraZeneca and University of Oxford’s vaccine uses technology from an Oxford spinout company, Vaccitech. It deploys a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees. It contains the genetic materials of the spike protein. After vaccination, the cells produce the spike protein, stimulating the immune system to attack the SARS-CoV-2 virus.
Type: Adenovirus-based
Doses: 2, 28 Days Apart
Likely EUA Date: Possibly January 2021, but unclear in the U.S.
Doses by Year End: Potentially 30 Million
Price: $3 per dose, potentially, but variable by market
Johnson & Johnson
Johnson & Johnson announced on November 15 that it initiated a second global Phase III trial of its Janssen COVID-19 vaccine. They expect to enroll up to 60,000 volunteers worldwide.
Whereas all of the other three vaccine candidates require two doses about 28 days apart, the J&J vaccine only requires a single dose. Interim results from its Phase I/IIa trial demonstrated a single dose of the vaccine induced a robust immune response and was generally well-tolerated. The ENSEMBLE 2 study evaluated a two-dose regimen as well.
The vaccine uses the company’s AdVac technology platform, which it used to develop its approved Ebola vaccine and its Zika, RSV and HIV investigational vaccine candidates. It revolves around the use of an inactivated common cold virus, similar to what the AstraZeneca-University of Oxford program utilizes.
Type: Adenovirus-based
Doses: 1
Likely EUA Date: Possibly March or April 2021
Doses by Year End: Projects 1 billion by end of 2021
Price: $10 per dose
Russia’s Sputnik V Vaccine
Around November 11, Russia’s National Research Center for Epidemiology and Microbiology, which Russia authorized for use in August—ahead of even beginning a Phase III trial—claimed had an efficacy rate of 92% after the second dose. It was based on a first interim analysis 21 days after the first injection during the ongoing Phase III study. On November 24, the organization claimed 95% efficacy based on new preliminary data. It also offered to share one of its two human adenoviral vectors with AstraZeneca to increase the efficacy of the AstraZeneca vaccine.
Russia’s Gamaleya research institute appears to be focused on potentially marketing their vaccine worldwide. Even the name of the vaccine has emphasized the idea of a race. The organization has indicated a dose of the vaccine will cost no more than $10, about half the cost of the Pfizer vaccine. The organization has also predicted they could produce 1 billion doses in the next year. At this time, aside from Russia, it will potentially be sold in India, Korea, Brazil, China, and Hungary. The Hungarian government is the only European Union country to express interest to date.
Type: Adenovirus-based
Doses: 2
Likely EUA Date: Not applicable in the U.S.
Doses by Year End: Projects 500 million by end of 2021
Price: $10 per dose
운송, 보관 측면에서 가장 현실성 있는 백신은 아스트라제네카 백신이 아닐까? mRNA 보다 아데노바이러스 기반이 더 안정성이 높을 것 같기도.