All I Want For Christmas is a Covid-19 Vaccine

​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:

• Dosage: 2 injections, 21 days apart.
• Age Groups Approved For: 16 years and older.
• Effectiveness: 95%.
• Adverse Reactions: Mostly mild and resolve within 48 hours. Injection site pain, fatigue, headache, muscle pain, chills, joint pain, and fever. There have been a few rare occurrences of severe allergic reactions.  The FDA is investigating at least five reports of severe allergic reactions in people soon after receiving the vaccine. The allergen is suspected of being polyethylene glycol, which is not uncommon in pharmaceutical preparations.
• Contraindications: Not to be administered to individuals with a known history of allergic reactions to any component of the vaccine.
• Warnings: Appropriate medical treatment used to manage allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine. The FDA also recommends that patients who have developed allergic reactions to other vaccines should be monitored for at least 30 minutes after the injection. All others should be observed for 15 minutes.
• Disadvantages:

1.  Storage: Must be stored at ultra-cold temperatures (-103°F). This requires expensive, ultra-   cold freezers, and must be packed in dry ice during shipping.
2.  Preparation: Once the vaccine vials are thawed, they need to be diluted with 0.9% Sodium       Chloride Injection, USP. This increases the cost of the vaccine and could be problematic in     some settings.   

• ​Other:

1. The vaccine is safe in people who have previously had COVID-19.
2. It is unknown how long protection against COVID-19 will last.
3. It is unknown if the vaccine will prevent an individual from spreading the virus.
4. Not recommended in pregnant and nursing mothers until further testing is done. However, the American College of Obstetricians and Gynecologists recommends that vaccines “should not be withheld from pregnant or lactating women who would otherwise qualify for the 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.
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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:

• Dosage: 2 injections, 28 days apart.
• Age Groups Approved For: 18 years and older.
• Effectiveness: 94.1%.
• Adverse Reactions: Similar to, but somewhat more prevalent than the Pfizer vaccine. Injection site pain, fatigue, headache, muscle pain, chills, joint pain, and fever.  
• Contraindications and Warnings: The same as for the Pfizer vaccine.
• Advantages:
  1. Storage: Can be stored at normal freezer temperature (-13°F to 5°F). Under normal refrigeration it is stable for up to 30 days.
  2. Preparation: Once the vaccine vials are thawed, they are ready for use. No additional supplies are needed to prepare the vaccine.
• Other:
  1. The vaccine is safe in people who have previously had COVID-19.
  2. It is unknown how long protection against COVID-19 will last.
  3. It is unknown if the vaccine will prevent an individual from spreading the virus.
  4. Not recommended in pregnant and nursing mothers until further testing is done.

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.:

• AstraZeneca/University of Oxford: It is inexpensive to make and can be stored at normal refrigerator temperature, but it is several months away from FDA consideration. Earlier studies indicate that it is less effective than either the Pfizer or Moderna vaccines, and the exact dosing regimen is yet to be determined. Phase III trials are being repeated due to dosing errors in the first trials.  

• Sanofi/GlaxoSmithKline: The initial formulation proved ineffective in elderly patients, so its back to the laboratory for this vaccine. Phase III trials won’t begin on the reformulated vaccine until the middle of 2021.

• Johnson & Johnson: Earlier studies indicate that the vaccine is highly effective with a single dose. The vaccine can be stored at normal refrigerator temperatures, so this is the vaccine to watch. Large scale, multi-country Phase III trials are currently underway. If the data from the trials indicate that the vaccine is safe and effective, J&J expects to seek Emergency Use Authorization from the FDA in February of 2021. 

• Novavax: Early studies are promising, but Phase III trials in the U.S. have been delayed due to manufacturing problems. Phase III trials in the U.S. are expected to begin by the end of this month. Look for this vaccine in the 2nd half of 2021.​​

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• No other vaccines funded by Operation Warp Speed are showing much promise. ​

The U.S. government now has agreements to purchase 200 millions doses of vaccine from Moderna and 200 million doses from Pfizer. That is enough for 200 million people out of the estimated 260 million Americans currently eligible to be vaccinated. 

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:

• Vaccine Mistrust: The CDC estimates that 70-80% of the population will need to be vaccinated in order to achieve herd immunity. There will need to be a massive outreach program at all levels of government, as well as with community and religious organizations. This will not be easy or inexpensive. The politicization of the coronavirus pandemic, and missteps by the federal government, have not created an environment conducive to a massive vaccination program. It may be an even harder sell in communities of color which have been disproportionately affected by the pandemic.
• Cost to States: Between $8-$9 billion will be required by financially strapped states to carry out the vaccination program. Supplies, personnel, special storage facilities, record keeping, and coordinating the 2nd round of vaccinations will all be required.  

• 3rd World Countries: The world is highly integrated with travel and trade. Even if everyone in the U.S. is vaccinated, we will not be completely safe from the virus until the majority of the world’s population has been vaccinated. The high cost and ultra-cold storage required for the Pfizer vaccine, make it a poor candidate for developing countries. The COVAX Alliance, led by the World Health Organization, is working with rich countries to provide COVID vaccines for poor ones. The organization hopes to use the AstraZeneca vaccine which will be cheaper to procure and doesn’t require restrictive storage and handling. Unfortunately, the vaccine is still many months away from FDA evaluation.
• Distribution Problems: The rollout of the Pfizer vaccine has been rocky. Pfizer will not be able to meet its overly optimistic goal of 20 million doses delivered in the U.S. by the end of 2020. Miscommunications between the head of Operation Warp Speed and the states have led to confusion, making vaccination planning difficult at the state level. As more vaccines become available, it just makes the coordination between the government and the states more complex. 

​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.
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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. 

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Thanks,
Armchair American