COVID-19 Vaccines
Contents
COVID-19 Vaccines
May 15, 2020
POTUS announces "Operation Warp Speed," the administration's national program to accelerate the development, manufacturing, and distribution of COVID-19 medical countermeasures. DOD will join key agencies in the public-private partnership to support in diagnostics, therapeutics, vaccines, production and distribution, and security and assistance. Source: White House Remarks
Source: US Department of Defence Coronavirus Timeline
...it’s not vaccines that will stop the pandemic, it’s vaccination.
Source: WHO COVID-19 vaccines
Vaccine Development - Operation Warp Speed
U.S. President Donald Trump was still in the White House when Operation Warp Speed (OWS) was initiated. However, since Joe Biden was inaugurated as the 46th president of the United States on 20 January 2021, this operation has been largely forgotten. The U.S. Department of Defence maintains a section for OWS but eventually that will be removed and archived[1]. An overview of OWS has been extracted from the site (as at July 2021), below:-
Overview
On May 15, 2020 the White House announced Operation Warp Speed to accelerate development, production, and distribution of COVID-19 vaccines, therapeutics, and diagnostics to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021.
Contributing Stakeholders: Department of Defense, Department of Health and Human Services, including the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the National Institutes of Health and the Biomedical Advanced Research and Development Authority.
OWS has five focus areas: Development and testing of vaccines; development and testing of therapeutics; development and testing of diagnostics; supply production and distribution of vaccines, diagnostics and therapeutics; security and assurance of vaccine, diagnostic and therapeutic development, testing, supply, production and distribution.
Source: U.S. Department of Defence CORONAVIRUS: OPERATION WARP SPEED
Reading through the OWS website, you will gain an understanding of how the COVID-19 vaccines were produced so quickly and why the mRNA vaccines were promoted when that was new technology.
Three COVID-19 vaccines were subsequently given Emergency Use Authorization in the US.
COVID-19 Vaccines given Emergency Use Authorization in the U.S.
Details about each vaccine are linked from the list below:-
- Pfizer-BioNtech
- Moderna
- Janssen/Johnson & Johnson
Other COVID-19 Vaccines
COVID-19 Vaccines listed here were not part of Operation Warp Speed.
- Vaxzevria (formerly AstraZeneca)
Vaccine Adverse Reactions
Thousands of people participated in trials for each vaccine, but only half would have received the vaccine being trialled. And for vaccines requiring two doses, not all participants received their second dose.
By contrast, the roll-out of the vaccines under Emergency Use Authorizations has involved millions of doses per country, or billions world-wide.It is not surprising therefore that there have been a significant number of adverse events following immunization (AEFI).
What is of concern, however, is the serious nature of many of these AEFI reports: medical conditions which require hospitalisation; permanent disability; neurological conditions; and deaths. People in good health have died after being vaccinated to save themselves from death by COVID-19.
Two articles are relevant to this topic:-
- AEFI Data and instructions on how to obtain up-to-date information is linked from the article Pandemic/Statistics.
- Adverse Events Following Immunisation (AEFI)
Benefits outweigh the risks
The mantra that the benefits (of the vaccines) outweigh the risks (of getting COVID-19 or dying) has been stated by the World Health Organization and repeated by health authorities in every member country.
The pandemic is a global health emergency and the country-based health authorities are public[2] health experts. From a public health perspective, this mantra is reasonable, perhaps even true.
However, the narrative that vaccines are the only way out of the pandemic is based on a statement or belief that there is currently no effective treatment for COVID-19. Since the new vaccines could only be given emergency use authorization if there were no effective treatments it was important to ensure that potentially effective treatments became unavailable or un-authorized. Therefore the population has a limited choice - risk getting COVID-19 with the possibility of death, or long-covid as a survivor; or accept a vaccine which may involve an adverse reaction, limited medical support if that occurs, and the manufacturers, health authorities, local doctors etc have no liability.
A re-phrasing of this mantra would be that the society or population gets the benefits of mass vaccination while the individual carries all the risks. Worth thinking about...
Vaccine Documentation
There are three types of documentation available for each vaccine, all are publicly available, but sometimes hard to find. These are:-
- Information for Recipients
This is the leaflet or handout which people get at a vaccination centre or from their doctor when they have received the vaccination. It typically explains what the vaccine is intended to do, side effects common to most vaccines such as a sore arm, tiredness etc, and who to contact if anything more serious happens. Advice will be worded 'ask your health care professional' without much detail. - Information for Health Care Providers
This is generally multi-page and written in a more technical style. If any adverse reactions are known they will be described more fully so that, as the health care provider, you can respond to questions with some detail. This document usually provides guidance for those administering vaccines, also ensuring they will be prepared if a recipient suffers an allergic reaction, faints etc, including medications and facilities which should be available if such an event occurs. - The Emergency Use Authorization
This document may have different names depending on a country's legislation.
The EUA describes the vaccine in detail, summarises the trial results, notes the occurrence of AEFIs both during the trial and since, lists the ingredients, and may run to many pages of technical and statistical text. Ideally, every family doctor will read the relevant EUA for vaccines available in their area.
EUAs are updated as the regulating body changes the conditions of approval or includes new or updated information. If the EUA is updated then the Information for Health Care Providers may also be changed. The Information For Recipients has less detail so may be unaffected by revisions.
The information about each COVID-19 vaccine linked from this page is collated from these documents from the United States, the UK, the EU, and possibly Australia. The most detail seems to be the country of origin of the vaccine or the European Medical Agency (EMA) which is very thorough. Links to relevant documents have also been included.
References
- ↑ Archived snapshots for Operation Warp Speed on The Wayback Machine at https://web.archive.org/web/*/https://www.defense.gov/Explore/Spotlight/Coronavirus/Operation-Warp-Speed/
- ↑ Most doctors, General Practitioners, know their patients by name and often get to know a whole family. GPs are concerned with the welfare of each individual. Similarly, doctors who are based in hospitals treat each individual patient as a person. Public health officials, however do not know each person in a population. Being human they will react emotionally to specific cases but overall they have been desensitised and public health is relies on data. No-one can deal personally with the emotional toll of thousands of deaths due to a pandemic. It is the role of public health experts to advise politicians and save the population. They don't know you. So for advice see your own doctor.
