COVID 19 Vaccines: Part I – The USA

In this and the next blog on COVID-19, I have tried to provide myself with a synthesis of the updated information on the development and distribution of vaccines. There is nothing in these two blogs that can be considered original or valuable as interpretation. Rather, the blogs simply summarize knowledge which others may find valuable to share.

In December, the United States will reach the peak of the COVID-19 pandemic. The U.S. has had almost 14 million cases. 270,000 have died from the disease. The average number of cases per day now total over 162,000, an increase of over 12% from the two previous weeks. Death rates have increased over 26% from two weeks ago.

However, in this same month in the U.S., the direction of the war will be reversed, the vaccine assault on the disease will commence and during 2021 we can look forward to the retreat of this disease in America. Moncef Slaoui is the chief science adviser to Operation Warp Speed. He is a Moroccan-born retired vaccine developer and drug company executive who currently co-coordinates Operation Warp Speed with Gustave Perna, a US Army four-star general responsible for logistics. Slaoui spent nearly 30 years at pharmaceutical giant GlaxoSmithKline (GSK), 27 of them working on a vaccine for malaria. He brought 14 vaccines to market and rose to head research and development for the entire company. The fastest a vaccine had ever been developed was the one for mumps; it took four years.

Slaoui will earn a total of $1001 for his role on Operation Warp Speed. However, his financial sacrifice has been much greater, for he resigned from the board of Moderna and gave up his stock options, but also sold all his stock, resigned from the board of the manufacturing firm, Lonza, responsible for producing Moderna’s vaccine. In addition, he resigned from Bril Biosciences, Artizan Biosciences and Clazado.

Slaoui has been giving a number of interviews through The New York Times, The Washington Post and other outlets to update the public on the impending counter-offensive against the COVID-19 pandemic. This is a summary of what he and other sources have had to stay about the arrival of the vaccines, their effectiveness and their distribution in America.

There is a strict separation between the U.S. Food and Drug Administration (FDA) and Operation Warp Speed initiated on 15 May 2020. They have different personnel and different functions. The FDA is charged with certifying the vaccines in the various stages of development and for final use. The FDA ensures that the companies involved in creating and producing the various vaccines do a thorough in-depth job with scientific rigor and appropriate scientific consultation.

Warp Speed, on the other hand, in addition to its responsibility for communication with other vaccine production operations around the world, is charged with coordinating the research by the six American companies involved in producing vaccines. In addition to Pfizer and its German collaborator, BioNTech, that has already received FDA emergency authorization, and Moderna, which has applied for emergency authorization, (the first two companies to pass the finish line), there are also:

  • Novavax, a small-cap vaccine biotech with a manufacturing capacity for approximately 2.75 billion doses of its vaccine candidate, NVX-CoV2373, has also been granted Fast Track Designation
  • AstraZeneca, a European drug giant in partnership with the University of Oxford based uniquely on the use of a genetically altered adenovirus (that is, a cold virus), with contracts in place to manufacture up to 2 billion doses of its vaccine candidate; in its initial trial, it has proven to be 90% effective when the initial dose by mistake was cut in half based on 2,800 volunteers, but only 62% effective with an initial full first dose; there have been no serious side effects, but the trials were paused when some volunteers experienced neurological problems which disappeared; This is the vaccine that is:
    • Much easier to store – does not require temperatures of -72 degrees
    • Much easier to mass produce
    • Costs one-fifth the price at $3-4 per dose
  • Johnson & Johnson, one of the first pharmaceutical companies to receive a major grant from the federal government, also has an adenovirus-based single dose vaccine; so is the Russian one called Sputnik V already being distributed on an emergency basis 
  • Sanofi (S-protein COVID-19 antigen based on recombinant DNA duplicating a genetic match for a surface protein on COVID-19) and GlaxoSmithKline (GSK) with a $2.1 billion contract with the U.S. federal government for 100 million doses of its vaccine based on both companies’ adjuvanted innovative technology; note that the combination of a protein-based antigen together with an adjuvant to enhance the immune response, creates a stronger and longer lasting immunity against infections than the vaccine alone and can be manufactured at scale. 

(In Part II on Canada and the World, I will indicate what other vaccines are under development.)

Moderna and AstraZeneca  are using the HEK-293 cell line derived from kidney tissue taken from a healthy baby aborted in the Netherlands in the 1970s. Johnson & Johnson is using the PER.C6 cell line developed from retinal tissue from a baby aborted in the 1980s. Anti-abortion activists have been upset by this source and for some this may be an inhibition in taking the vaccine.

One hundred million doses will vaccinate 50 million people since most vaccines require double doses. Everyone is excited now that three of the vaccines under development have already passed Phase III trials with flying colours and two still await approval.

In the FDA’s independence and responsibility for quality control, there is some communication with Operation Warp Speed with respect to testing, manufacturing and even distribution to ensure the safe use of the vaccines. Operation Warp Speed has followed the imperatives Slaoui laid down when he took the co-coordinator and chief scientific advisor role. No political interference. No bureaucratic interventions. Science, not politics or administrative practices, would lead the way. Six months and four days after the contract was signed, Pfizer and its German collaborator, BioNTech, were the first across the finishing line. The vaccine awaits final formal approval; manufacturing and distribution will follow, likely by mid-December following an approval meeting on 11 December.

The U.S. Centre for Disease Control and Prevention (CDC) is charged with ensuring the quickest, widest and fairest distribution of the vaccines and recommending to states the priorities on vaccination. CDC releases the data it accumulates on infected persons, hospitalized patients with COVID-19, numbers that enter intensive care units (ICUs), and deaths from COVID-19. It also makes recommendations on prevention and mitigation – lockdowns, stay-at-home, masks, distancing, numbers relatively safe to gather indoors and out, tracing when there is a disease spreader, and monitors the success of different treatments.

Warp Speed is not only responsible for coordinating the research and manufacturing of various vaccines, but overseeing all aspects of the distribution and logistics. The objective is that within 24 hours of approval, the vaccines will be shipped to specified addresses in each state using FedEx and UPS for example in temperature-controlled shipping after first arriving from Belgium. (The temperature must be -94 degrees Fahrenheit) Pfizer is currently studying whether the vaccine can be transported at higher temperatures. The problem will come with local storage at the low temperatures for local distribution nodes. Evidently, the syringes, swabs and other materials needed to administer the vaccines are already at the required locations. There have already been dry runs to deliver the boxes of vaccines of the right size and weight as part of the preparedness.  However, one estimate has given a figure of 50,000 deep cold refrigeration units needed for the various points of distribution around America.

Operation Warp Speed has been managed totally independently of the chaos in the White House and there has been no impact or even attempt evidently to influence its operations. Its decisions are guided strictly by technical, scientific and ethical data and norms. It has been helped enormously by the fact that both Pfizer and Moderna have been both very successful and swift in their development, but have also provided plenty of data that has been plentiful, robust and of excellent quality to indicate effectiveness and safety.

The best news has been the results of the trials with both vaccines. They are 95% and 94.5% effective on average and 100% effective for people with serious conditions after the two vaccines have both been through three stages of trials and 50,000 individuals have been vaccinated. About 15% exhibit typical side effects from the inoculation of the vaccines – pain in the arm, red swelling a rash, a small fever, but the symptoms are not long lasting.

There have been no measures for any long-term effects of the vaccines. But there have been no adverse effects at all in the shorter term other than the symptoms exhibited from the insertion of the vaccine. Some confidence that there will be none comes from the biological signals and data base in these and other clinical trials. Adverse effects, if any, occur within 40 days after immunization. Thus, although there is no way to really predict, and only time will tell, a great deal of confidence can be suggested that long term effects simply will not happen. In any case, when considering the alternative risk of getting the disease, the illness that results from infections, the hospitalizations and even deaths, the probabilities overwhelmingly favour taking the vaccine.

By the end of 2020 – that is this year – 40 million doses will have been produced and 20 million people vaccinated. The most vulnerable front-line health workers and those in long-term care facilities (24 million in total) will get the first doses. By the end of January, 80 million additional doses will be ready and 40 more million vaccinated. It is expected that essential workers and older adults will be next in line to receive the vaccine. Health and Human Services Secretary Alex Azar, “has insisted that science and data drive the process…for vaccine allocation and distribution” as it did for vaccines and therapeutic development. Since other vaccines are expected to be ready in February and March, it is easy to extrapolate and calculate that by the end of June 2021, every American who wants to be vaccinated will be.

In the meanwhile, what about cautionary measures – testing, masks, distancing, size of gatherings, tracing, etc.? Since the median time that people test positive is five days after exposure, and it could take up to two weeks, one might expect some individuals who receive the vaccine to develop COVID-19 because the disease was on its way before the inoculation. Whether the vaccine slows down the process or mitigates its effects has not been determined. The CDC has issued a new recommendation modifying its previous requirement of two weeks of quarantine for anyone that may have been in contact with an infected person.

The agency’s new recommendation has reduced the quarantine period to a ten or, in some cases, a seven-day quarantine periods. With the 10-day option used in France and Germany, about 1 percent of infections will be missed. With the seven-day option, which requires a negative test at the end, 5 percent of infections will be missed. If a person was definitely in contact with an infected person, a 14-day quarantine period is still recommended by CDC.

The pieces of the puzzle are in place to defeat the disease. To Be Continued.

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