Joy to the world, the vaccines have come. Let earth begin to heal. Let's thank those who delivered them; let every arm prepare for one; and heaven and nature sing, and heaven and nature sing, and heaven and heaven, and nature sing. Is this a Christmas miracle? Let’s not get ahead of ourselves. This is still 2020 after all, and we have a long road ahead. The two COVID-19 vaccines currently in limited distribution were developed in record time, but the development of the technologies behind the vaccines took decades. Let’s look at the two vaccines currently being distributed and what to expect in the coming months. Operation Warp Speed (OWS): 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 (https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html). This is an interagency program spearheaded by the Department of Health and Human Services. The main goal of this program is to produce and deliver 300 million doses of safe and effective vaccines, with the initial doses available by 2021. So far so good. The Chief Operating Officer of the program is General Gustave Perna, and the Chief Scientific Advisor is Moncef Slaoui. In August, OWS chose six companies to receive funding in order to expedite development and manufacture of COVID-19 vaccines. These companies are Johnson & Johnson, Moderna, Astra Zeneca/University of Oxford, Novavax, Merck, and Sanofi/GlaxoSmith Kline. Pfizer/BioNTech did not receive any direct funding from OWS, but has agreed to supply vaccines. Pfizer/BioNTech COVID-19 Vaccine: This vaccine was given Emergency Use Authorization (EUA) by the FDA on December 11, 2020. This is not the same as a full FDA approval, but it allows the vaccine to be used because there is sufficient evidence to show that its potential benefits outweigh its risks. Nearly 3 million doses of vaccine were delivered over the last ten days to 636 sites across the U.S. An additional 3 million doses will be delivered over the next few weeks to complete the required two dose regimen. Twenty to thirty million doses will be delivered each month in the first quarter of 2021. The first vaccines began to be administered to frontline healthcare workers on December 14, 2020. The vaccine was developed in Germany by BioNTech using mRNA technology (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html). BioNTech has partnered with Pfizer to help fund, manufacture, and distribute the vaccine. OWS has contracted with Pfizer to purchase 100 million doses of the vaccine for $1.95 billion. Pfizer will produce about 1.3 billion doses of the vaccine in 2021 to be distributed around the world. The U.S. government is currently negotiating with Pfizer for an additional 100 million doses of vaccine, but Pfizer lacks the required raw materials. The government is considering using the Defense Production Act to speed up production of the needed materials. In an interview with CNBC, Pfizer CEO Albert Bourla said he would welcome the U.S. government’s help in procuring needed materials in order to increase production of the vaccine. This just in: Today (12/23), Pfizer and BioNTech have signed a $2 billion agreement with the U.S. government for the purchase of an additional 100 million doses of COVID-19 vaccine. At least 70 million doses will be delivered by June 30, 2020, and the remaining 30 millions doses will be delivered no later than July 31, 2020. What You Need to Know About the Pfizer Vaccine:
You can find more information on the Emergency Use Authorization of the Pfizer Covid-19 vaccine at: (https://www.fda.gov/media/144414/download). Moderna COVID-19 Vaccine: This vaccine was given Emergency Use Authorization by the FDA on December 18, 2020. The FDA stated that its analysis “supported a favorable profile”, and confirmed Moderna’s earlier assessment that its vaccine was 94.1% effective. Administration of this vaccine began on December 21, 2020. The Moderna vaccine is roughly equivalent to the Pfizer vaccine, both of which use synthetic messenger RNA technology. Moderna is a small biotech company based in Cambridge, Massachusetts, and the vaccine is the first product it has brought to market. Moderna will rely on contract manufacturers, such as Catalent Biologics in Indiana, to package and distribute their product. They plan to produce 500 million doses in 2021. Unlike Pfizer, Moderna has worked closely with Operation Warp Speed. The vaccine was developed in partnership with the National Institute of Allergy and Infectious Diseases, under-written by the government. Last summer the government signed a contract to purchase 100 million doses of the vaccine to be delivered in the first quarter of 2021. Earlier this month the government signed another agreement to purchase an additional 100 million doses to be delivered by the end of the 2nd quarter. This brings the government’s investment in the Moderna vaccine to $4.1 billion. What You Need to Know About the Moderna Vaccine:
You can find more information on the Emergency Use Authorization of the Moderna Covid-19 vaccine at: (https://www.modernatx.com/covid19vaccine-eua/). Other COVID-19 Vaccines on the Horizon in the U.S.:
Vaccine Distribution: Operation Warp Speed is coordinating distribution of all vaccines. It is allocating vaccines according to each state’s population. The CDC has established guidelines to aid the states in prioritizing the limited supply of vaccines. The individual states have the final say on how the vaccines will be distributed, but most states will follow the CDC guidelines. The highest priority (Phase 1a) will be frontline healthcare workers and older people and staff in residential care homes. The CDC just released new guidelines for people in the next priority group (Phase 1b). This group includes people 75 and older, and frontline workers in “essential” jobs. These essential workers include teachers, emergency workers, and people who work in grocery stores, prisons, food processing plants, and public transportation. It will probably take most of the 1st quarter of 2021 to vaccinate this group of people, assuming no supply disruptions. The next group (Phase 1c) will be people aged 65-74, and younger people with high- risk health conditions. Even if we wanted to vaccinate everyone sooner, the supply just isn’t there. Phase I alone will use most of the vaccines currently contracted for through Operation Warp Speed. The country will need at least one more approved vaccine to get all of the general public vaccinated by the end of the summer. The National Governors Association and Duke University have developed a website to help navigate the vaccine distribution across the country. For your state’s specific plan follow this link: (https://healthpolicy.duke.edu/news/covid-19-vaccination-plans-state). The CDC has established the “Pharmacy Partnership for Long-Term Care” to offer onsite COVID-19 vaccination services for residents and staff of nursing homes and assisted living facilities. The participating pharmacies include CVS, Walgreens, and Managed Health Care Associates. How Much Will the Vaccine Cost?: The federal government (tax payers) is paying for the vaccine. Healthcare providers may charge an administration fee, but in most cases this will be covered by medical insurance. Will Vaccination be Mandatory?: At this time vaccination is voluntary. It would be legally questionable to mandate vaccination with a product that has not received full FDA approval. But it is likely that there will be travel restrictions put in place requiring people to be vaccinated before flying or entering certain foreign countries. Will the Vaccines be Effective Against New Virus Variants: According to HHS officials and reports from Pfizer and Moderna, there is a high level of confidence that existing vaccines will be effective against new COVID variants, such as the one in the United Kingdom(UK). Moderna and Pfizer will conduct tests on the UK variant in the coming weeks to make certain that their vaccines are effective. Challenges Remain:
Vigilance and Patience: It will take most of 2021 to get the majority of the eligible people in the U.S. vaccinated against COVID-19. This is a massive effort and hiccups are bound to happen. We all just need to be patient. While we wait for herd immunity to be achieved, which could be many months to years away, we need to continue to protect ourselves, our families, and communities against the virus. This means that mask wearing, social distancing, and hand sanitation are as important as ever. Even after people become vaccinated, they may still shed the virus, so we must remain vigilant. New information about the coronavirus, COVID-19, and vaccines is coming out daily, so stay informed. The vaccines currently available, and those in development, give us hope for 2021. The efforts behind these vaccines demonstrate what can be accomplished when thousands of people in the public and private sectors come together in common cause for the betterment of humanity. The true Christmas miracle would be if this becomes a trend, and people come together to solve intractable problems like homelessness, poverty, hunger, racial injustice, the failed healthcare system, etc., etc., etc. One can only wish; and here’s wishing you a Merry Christmas. If you enjoy reading this type of commentary please subscribe to my blog and tell a friend. You will receive an email notification when new blogs are posted. The email will come from the site’s email: armchairamerican1776 @gmail.com.
Thanks, Armchair American
1 Comment
Eric I.
12/23/2020 01:47:53 pm
Fantastic information with a well done musical parody at the start, what more could we ask for! :)
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