VACCINE UPDATE = GREAT NEWS
I have hesitated in updating my notes on vaccines based on the lack of true scientific papers being submitted and information delivered exclusively by Press Release. Nevertheless, I have heard from some of you that you would like an update.
The results reported by Pfizer, Moderna and now Oxford/AZ have been even more positive that we could have hoped for. This is fantastic news.
We need to keep in mind that the results are only empirical; we don’t know the underlying mechanisms for success, only that statistically less people are becoming infected. We do not know at this time whether than result is because the vaccines stimulated a humoral immune response (antibodies and B-Cells), a cellular immune response (T-Cells) or some other mechanism, for example through interleukins and other protective secretions, or the ability to commandeer the internal mechanisms in the target cells.
We cannot know how long the vaccines will work since the entire history of this disease has covered only months. We won’t know longer-term protection until sufficient time passes to assess those protections.
This essay will address some specific points:
- What conclusions can we draw from the numbers in the Press Releases?
- How will the various vaccines be used?
- How basic scientific research prepared us for success.
- Will I get the vaccine?
WHAT CONCLUSIONS CAN WE DRAW?
The results from all three of the vaccines that have been reported have shown remarkably high percentages of “protection”. Remember that for example, Moderna and Pfizer have now studied about 70,000 people and within that group there was a total of about 300 infections, or less than 0.5%. This number, although statistically significant is still quite small and we really won’t know the actual protection numbers until widespread vaccinations occur in the larger population.
We can rightfully conclude that these vaccines will be effective in the general population.
Press suggestions are that even those patients that tested positive for virus among the vaccinated populations showed non-severe disease.
We can rightfully conclude that these vaccines appear to significantly reduce the potential for severe disease in those vaccinated; however, these results are based on vaccinating uninfected people and the results do not speak at all to whether these vaccines will have any effect on patients already infected.
HOW WILL WE USE THE DIFFERENT VACCINES?
There are now 3 vaccines that have completed the bulk of their phase 3 trials. Two of them are of a brand-new format, an mRNA vaccine, the third, a more traditional type of vaccine. We can expect at least 10 more successful vaccines completing Phase 3 trials over the next few months. So, do we need a dozen different vaccines? What would be the benefit?
Each vaccine will have a particular use profile, and the combination of the various vaccines will give us an arsenal of different tools for different uses.
For example, the Moderna vaccine requires less refrigeration than the Pfizer vaccine. Therefore, the Moderna vaccine is more suited to distribution through traditional outlets such as physician offices and pharmacies where standard freezers are already in place.
The Pfizer vaccine requires much lower temperatures for storage. It will be better suited for locations in which mobile refrigerated systems can be staged and where bulk vaccination is possible such as healthcare systems, nursing homes and assisted living centers, schools, prisons and other institutions.
For many locations both in rural areas and in other countries, even the level of refrigeration required by Moderna is not available. For these locations, a vaccine such as the AZ vaccine, which has a longer shelf life is most appropriate.
All three of these vaccines require 2 doses. This is fine for developed countries in which populations can be educated and for which follow up is achievable, but there will be other vaccines that only require single doses. These vaccines will be much more appropriate for locations in which successful multi-dose regimens are less likely to succeed.
We can expect to find over time that some of the vaccines will be more effective among different groups of people, either by age, ethnicity, health conditions, etc. These correlations will begin to tailor the vaccine to the individual.
The more vaccines approved, the larger the manufacturing capacity; and since we really need to vaccinate 5 billion people, we will need as large an inventory of vaccines as we can possible produce.
HOW DID SCIENCE PREPARE US FOR SUCCESS?
At the end of this essay is a timeline of the virus. I want to point out a few points in this timeline because it reflects how the global response to this virus has allowed the spectacularly fast release of vaccines.
The first case of this new virus in Wuhan occurred on December 31, 2019, a little over 10 months ago.
The “outbreak” was reported 5 days later and 4 days after that the Chinese had determined that the outbreak was the result of a novel virus.
On January 11, only 12 days after the first case was identified, the Chinese laboratories had completed the genetic sequence of the viral genome! The ability to sequence a genome in such a stunningly short time is the result of the scientific research into gene sequencing begun decades ago with the Human Genome Project, the commercial development of sequencers and the work of hundreds of scientists and laboratories, financed through governmental organizations such as the NIH and NSF over the past 40 years.
Two days later, on January 13, the first case outside of China was reported in Thailand, and on January 19, only 20 days after the first case was reported, the WHO reported that there was evidence of human-to-human transmission of this new virus.
On January 21 the first case in the US was reported.
For decades, in academic laboratories around the world, a dream of using mRNA as a vector for creating vaccines was researched, supported by private funds and governmental grants. The work, being basic research had no immediate ROI, so it was not pursued by commercial organizations. Over the past 10 years, sufficient advances had been realized that two startup companies, Moderna and BioNTech began to develop tools to bring these basic research findings to market. That work has now allowed for a potential breakthrough in vaccine production not only for this disease but for multiple diseases going forward.
I cannot stress strongly enough that it is the support of non-commercially viable basic research that leads to these tremendous strides forward. No commercial company will ever support this work, it is the responsibility of the government to support this work.
On top of this work, the Trump administration created Operation Warp Speed. This program appears to have been very successful. It was not, nor was it ever intended to be, a governmental program to develop a vaccine. Had that been a goal we would have seen a directed effort at the CDC or NIH.
What the program was, was an unprecedented government financed and managed program to produce vaccines in advance of approval, develop manufacturing capacity, storage, distribution and vaccination protocols. It also provided a form of financial backstop for the vaccine production companies by committing to purchase vaccines once approval was given. This was able to modulate the risk of those vaccine producers; and although the financial support was not directly delivered to the companies, they were able to move forward with the anticipation of payments for products once those products were approved for distribution and use.
WILL I GET THE VACCINE AND RECOMMEND IT TO OTHER?
Short answer: Once the vaccine has been reviewed through the FDA committee, the independent expert committee and the CDC review committee (all standard models), and the vaccine is approved as I fully expect it will, I will get the vaccine as soon as I am eligible. I will highly recommend that everyone get the vaccine. I am a very strong advocate for the use of vaccines and have always lobbied everyone I know for getting the Influenza vaccine and am a strong advocate for all college-bound students to get the pneumococcal pneumonia vaccine.
Please, please remember that these soon-to-be-approved vaccines require 2 doses, separated by between 3 and 4 weeks, and the results that have been provided only demonstrate that immunity is conferred AFTER the two doses, and most likely not until at least 28 days after the first immunization. DO NOT let your guard down the day after you have been vaccinated. YOU ARE NOT protected immediately. The protection is conveyed after 28 days. You need to continue to protect yourself through physical distancing, mask wearing and personal hygiene for 4 weeks after you get vaccinated.
THE TIMELINE OF COVID-19
- December 31, 2019: Statement from Wuhan Municipal Health Commission on a new pneumonia of unknown origin.
- January 1, 2020: WHO activated its Incident Management Support Team (IMST).
- January 2: WHO informed Global Outbreak Alert and Response Network (GOARN) partners about the cluster of pneumonia cases in the People’s Republic of China.
- January 5: WHO shared detailed information about a cluster of cases of pneumonia of unknown cause through the IHR (2005) Event Information System.
- January 9: WHO reported Chinese authorities determined that the outbreak is caused by a novel coronavirus.
- January 11: WHO received the genetic sequences for the novel coronavirus from China.
- January 11: China reported the first death from the novel coronavirus.
- January 13: Thailand reports first recorded case outside of China.
- January 13: WHO publishes first protocol for a RT-PCR assay to diagnose the novel coronavirus.
- January 14: WHO: “it is certainly possible that there is limited human-to-human transmission”.
- January 19: WHO: there is evidence of limited human-to-human transmission.
- January 20: WHO mission to Wuhan: evidence suggests human-to-human transmission in Wuhan but that more investigation was needed to understand the full extent o transmission.
- January 21: The US reported its first confirmed case of the novel coronavirus.
- January 28: WHO published advice on the use of masks in the community, during home care and in health care settings.
- January 30: WHO declared the novel coronavirus outbreak a public health emergency of international concern (PHEIC), WHO's highest level of alarm.
- February 2: First dispatch of RT-PCR lab diagnostic kits shipped.
- February 11: WHO announced that the disease caused by the novel coronavirus would be named COVID-19.
- February 24: WHO-China Joint Mission on COVID-19 reported on their main findings.
The Mission stressed that “to reduce COVID-19 illness and death, near-term readiness planning must embrace the large-scale implementation of high-quality, non-pharmaceutical public health measures”, such as case detection and isolation, contact tracing and monitoring/quarantining and community engagement. - February 27: WHO guidance on the personal use of PPE considering the shortages of these items in healthcare settings.
- March 11: WHO characterized COVID-19 as a pandemic.
- March 18: WHO and partners launched the Solidarity trial to generate robust data from around the world to find the most effective treatments for COVID-19.
- April 2: WHO reported on evidence of transmission from symptomatic, pre-symptomatic and asymptomatic people infected with COVID-19, noting that transmission from a pre-symptomatic case can occur before symptom onset.
- April 6: WHO updated guidance on masks, including a new section on advice to decision-makers on mask use by healthy people in communities.