vperdigon: October 2021

I am a citizen, a taxpayer and a voter. I am endowed with the right to choose and freedom of expression by God and the Constitution. I will decide as wisely as I can. I will not criticize others who do the same but only those who sell or buy votes. I will not argue for my or against anyone’s choice that there may be goodwill among us all. The candidate is fair game, open to any scrutiny of his or her potential to lead. Be that as it may, I will respect his or her dignity and put him or her to task only on matters relevant to public service. I will not belittle him or her for physical condition, mental ability, educational degree or financial status. I will judge him or her solely on my perception of his or her track record, platform, evidence of sincerity, manifest character and ability to inspire others. Then I will keep such judgment to myself. Let my conscience grant me peace when I have thus decided.

So help me God.

Why Vaccination Cannot be Mandatory

If you will sacrifice the few in order to save the many, then that is immoral. Ask the few to volunteer and that would be fine! To coerce them betrays the authority’s pledge to protect everyone under the law. Not even God, who knows everything, coerces us. He gives us the choice through freewill.

You cannot ram even the most delicious food down the throat of anyone.

But the vaccines are not at par with delicious food. Their safety is not proven yet unlike that of the previous vaccines for example for measles, polio and diphtheria. The FDA states in its article titled “Emergency Use for Vaccines Explained”

An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.

Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.

Are the COVID-19 vaccines rigorously tested?

Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness. These clinical trials are being conducted according to the rigorous standards set forth by the FDA.

Initially, in phase 1, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people. In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies. These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and may provide initial information regarding the effectiveness of the vaccine. In phase 3, the vaccine is generally administered to thousands of people in randomized, controlled studies involving broad demographic groups (i.e., the population intended for use of the vaccine) and generates critical information on effectiveness and additional important safety data. This phase provides additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo.

What are the plans for continued monitoring of COVID-19 vaccines authorized by FDA for emergency use?

FDA expects vaccine manufacturers to include in their EUA requests a plan for active follow-up for safety, including deaths, hospitalizations, and other serious or clinically significant adverse events, among individuals who receive the vaccine under an EUA, to inform ongoing benefit-risk determinations to support continuation of the EUA.

FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure (approval).

Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist. There will be multiple, complementary systems in place with validated analytic methods that can rapidly detect signals for possible vaccine safety problems. The U.S. government has a well-established post-authorization/post-approval vaccine safety monitoring infrastructure that will be scaled up to meet the needs of a large-scale COVID-19 vaccination program. The U.S. government – in partnership with health systems, academic centers, and private sector partners – will use multiple existing vaccine safety monitoring systems to monitor COVID-19 vaccines in the post-authorization/approval period. Some of these systems are the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), the Biologics Effectiveness and Safety (BEST) Initiative, and Medicare claims data.

How will vaccine recipients be informed about the benefits and risks of any vaccine that receives an EUA?

FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website. (Boldfacing and red font colorization supplied.)

(https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained)

I lengthily quote the US FDA in order to avoid any wrong context.

There is also the false notion even among authorities that vaccination protects other people around a vaccinated person. This was claimed by CHED Chairman Prospero De Vera during a Zoom forum on October 1, 2021 from 9 am to 12 noon. I dare say this is wrong because according to medical science a vaccine elicits a response from the immune system of the vaccinated, not the persons surrounding him. Moreover, the vaccinated carries the virus with him. Therefore he can transmit it to persons around him. The unvaccinated has the same potential to infect others. It is down right wrong to think that only the latter can spread the virus. No wonder, after the vaccines were rolled out the daily increase in cases reached as high as 26,000 while it ranged between 5,000 and 10,000 before.

Another evidence that vaccines do not protect people around the vaccinated is RA 11525 Section 12 one of whose paragraphs reads:

Individuals vaccinated against Covid-19 as indicated in the vaccine card shall not be considered immune from Covid-19, unless otherwise declared by the DOH based on reliable scientific evidence and consensus.

When something is made mandatory, the mandating authority must bear responsibility for any consequence. In RA 11525, such responsibility is absent:

Section 8. – Notwithstanding any law to the contrary, public officials and employees, contractors, manufacturers, volunteers, and representatives of duly authorized private entities who are duly authorized to carry out and are actually carrying out the COVID-19 Vaccination Program shall be immune from suit and liability under Philippine laws with respect to all claims arising out of, related to, or resulting from the administration or use of COVID-19 vaccines under the COVID-19 Vaccination Program, except those arising from willful misconduct and gross negligence.

I pause for a reply.

October 2, 2021