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Friday, March 29, 2024

The Covid-19 Vaccine: The Basics

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"No vaccinated person has been hospitalized for, or died from COVID-19."

 

Monday this week, COVID-19 mass vaccinations officially rolled out in the Philippines.

On the last day of February, the Philippines received a shipment of 600,000 doses of Sinovac’s CoronaVac, a donation from the Chinese government. It is the first official shipment of COVID-19 vaccines to the country and follows the emergency use authorization (EUA) received from the local FDA on 22 February 2021.

A shipment of 525,600 doses of the AstraZeneca/Oxford vaccine, which received EUA in the last week of January, is expected next week, after having been postponed from its original 1 March schedule. Pfizer vaccines, first to be granted emergency use authorization (EUA) in the second week of January and expected to have been the first to be made available in the country, are not expected to arrive until April 2021 at the earliest.

Availability

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As soon as global consensus emerged that the only real way out of the COVID-19 pandemic was vaccines, it became clear that availability was going to be a critical concern for countries. In fact, many countries invested in vaccine development to ensure that vaccines would be manufactured on their shores in a bid to secure supply.

For a vaccine to become available, at least two things need to happen: the vaccine must receive approval for use by the Philippine Food and Drug Administration and the vaccine must then be purchased and delivered to the country.

Unlike other countries which concentrated on only a few suppliers, the Philippines early on began discussions with at least seven companies: AstraZeneca, Johnson & Johnson, Moderna, Novavax, Pfizer, China’s Sinovac Biotech and Russia’s Gamaleya Institute.

Vaccines from Pfizer and AstraZeneca received EUA in January and shipments were expected in February, including about 110,000 doses of the Pfizer/BioNTech that were a donation through the COVID-19 Vaccine Global Access (COVAX) initiative, an international effort to ensure that the vaccine be made available at least to high priority individuals (e.g. medical workers) in all countries. Both AstraZeneca and Pfizer deliveries were to have been purchased via COVAX and both were delayed owing to the lack of an indemnity agreement in the Philippines. The local representative of the WHO stated that the indemnity is a standard requirement of all vaccine manufacturers.

On 17 February, vaccine czar Carlito Galvez Jr. reported that indemnity agreements had been signed for both AstraZeneca and Pfizer. However, the availability of the Pfizer vaccine continued to be unclear. On February 23, WHO representative  Dr. Rabindra  Abeyasinghe  explained that all the indemnity agreements had been presented by the Philippine government in time but there had been delays owing to additional clauses required by Pfizer. These clauses are an addition to the standard indemnities and were presented by Pfizer in a side letter to the Philippine government.

On February 26, Philippine President Duterte signed into law an act providing COVID-19 vaccine makers from liability arising from the administration of the COVID-19 shots. This law covers all vaccinee makers and paves the way for fast-tracking the purchase of COVID-19 vaccines unless, of course, some of them like Pfizer insist on additional clauses.

For the three vaccines that have received FDA approval, all that remains is for the vaccines to be purchased and delivered. For the others, applications for approval must be submitted to the FDA and authorization granted.

Efficacy and Safety

Once vaccines are available, at least three questions need to be asked: 1) is the vaccine effective at preventing the disease, 2) is it effective at preventing spread of the disease and 3) what are the potential side effects?

Before we dive into available statistics, let us be clear about what is worrying about COVID-19. First, it is very easily transmitted, with the new strains (identified in South Africa and the UK) being even more contagious. Second, about a fifth of those infected experience severe symptoms requiring hospitalization, and about 1 percent of those infected, or about 5 percent of those with severe symptoms die.

What does this mean? If there had been no lockdowns and countries had allowed the virus to spread unchecked, then as many as 40 percent to 70 percent of the population could have contracted the disease. In the Philippines, assuming the estimated 109 million population in 2020, between 9 and 15 million people would have required hospitalization. Between a half million to a million people would have died. In fact, it is likely that deaths would have exceeded a million as the health care system would have been overwhelmed.

It must be clear that this nightmare scenario is still possible unless we can arrest the spread of the virus. What is important though is that the nightmare scenario does not come from those with mild symptoms. It comes from hospitalizations and deaths.

Now, when we compare efficacy rates of the various vaccines that may become available, we must remember that the efficacy rates are for prevention of symptomatic disease. This includes mild symptoms. What we need to worry about is the prevention of hospitalization and death.

And here is the important thing, expert after expert has pointed out an important point, the vaccines that have had widespread trials have been 100 percent effective at preventing severe forms of the disease and death. In a recent USA Today article discussing seven vaccines (AstaZeneca, Gamaleya, J&J, Moderna, Novavax, Pfizer and Sinovac), members of the Biden-Harris Transition COVID-19 Advisory Board, doctors and epidemiologists reiterate that so far, not a single vaccinated person has gotten sick enough to require hospitalization or has died of COVID-19. This is reiterated by Julia Ries in a February Huffpost article comparing five vaccines (AstaZeneca, J&J, Moderna, Novavax, and Pfizer).

So, are the vaccines effective for the most important purpose, the prevention of severe symptoms and death? Yes.

Will vaccination prevent the spread of the virus? Currently there is no evidence that vaccinated people cannot become carriers. Hence, the only way the vaccine can prevent the spread of the disease is to achieve herd immunity. This means that everyone who can receive the vaccine must be vaccinated.

Finally, is the vaccine safe? All the evidence so far shows that, except for a very few who may experience severe allergic reactions, the vaccines generally have either no or mild side effects. At this point, we must note that these side effects are the same as those that can be expected from most immunizations anyway, including a regular flu shot. There are a few people who should not take the vaccine at this point. First, children because the widespread trials have only been on adults. Second, those for whom the vaccine is contra-indicated. If you have demonstrated allergic reactions to the components of the vaccine, you should not get it. If you have an autoimmune disorder, you should seek physician advice before taking the vaccine.

What does this all mean? Quarantine protocols continue to stay in place until we hit herd immunity. We will not hit heard immunity until enough people (about 70 percent) of the population is immune. If you accept vaccination when it is made available to you, you are helping the country reach herd immunity. Without this, we are continuing to risk those who cannot take the vaccine because of their health condition.

We continue the discussion on COVID-19 in more detail next week.
 

Readers can email Maya at integrations_manila@yahoo.com. Or visit her site at http://integrations.tumblr.com.    

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