A new kind of hope 

Published December 28, 2020, 11:34 PM

by Dr. Edsel Salvana

Why we need to trust science

CLINICAL MATTERS

Dr. Edsel Maurice T. Salvana

Christmas holidays during a pandemic are very different from what we are used to. While some people are still planning parties, many more are keeping their gatherings small or completely virtual. Travel abroad and to the provinces is difficult or impossible. Perhaps one of the most compelling reasons to be with family now is that elderly parents and grandparents feel they do not have many Christmases left.

Covid-19 has stripped us of our ability to physically be with our loved ones, and the longing to be with each other is made more acute by the season. We usually take time out of our busy schedules to make the trip home, but this year it is tempered with the danger posed to our older family members.

This month finally saw the deployment of vaccines in the hardest hit areas of the world. An early Christmas gift to the world, vaccines represent our best hope in ending this pandemic once and for all. Unfortunately, there remains a lot of hesitancy, uncertainty, and fake news surrounding this life-saving achievement. Some concerns are valid, while the rest are borne out of misconceptions or inaccurate information.

EUA versus Full Approval

No vaccine has received approval worldwide for general use. Countries are currently using the two approved vaccines from Pfizer and Moderna to protect the vulnerable and their frontliners under an emergency use authorization (EUA) or an interim approval. This will likely be the scenario for authorizing the use of the vaccine in the Philippines.

Media and lay people are typically not familiar with the nitty-gritty of regulatory processes. When a drug or a vaccine applies for an authorization for use, it usually has to meet strict criteria for approval. These usually include Phase 3 data on efficacy and a certain length of time of observation for any safety issues. For most vaccines, the minimum amount of time for follow-up and observing the subjects in clinical trials is one year. This may be longer in some cases if the vaccine is intended for mass vaccination programs and it may not occur until a limited rollout and a Phase 4 post-marketing study has been done.

The current approvals for Covid-19 vaccines fall under Emergency Use Authorization (EUA) or (in some countries) interim approval. What does an EUA mean? The country invokes emergency rules where it can use vaccines that have recently undergone clinical trials showing good efficacy and a specified length of safety data for certain target populations. For Covid-19 vaccines, the minimum vaccine efficacy set is at least 50 percent while the minimum safety follow-up is two months. These are the parameters that the US FDA has deemed acceptable for protecting the most vulnerable.

Among the most at risk for severe Covid-19 are elderly people, those with chronic illnesses, and frontline healthcare workers. Currently the EUA in the US is for people 16 years old or above. Since there is a shortage, the government has drawn up a priority list to get the vaccine to those who are at highest risk for dying. An EUA also means mandatory close monitoring and safety reporting periodically from the manufacturer and ongoing review of the terms of use. 

Some misinformed individuals have been very vocal in social media that we should wait for full FDA approval before we deploy the vaccine locally. This is a dangerous misconception because no country has given full approval for any Covid-19 vaccine. There is not enough data to support use in the general population. Children certainly cannot receive it yet since the trials, which include kids, are just starting. Finally, a longer safety follow-up beyond two months may be needed to consider routine use in lower risk populations. 

We will be left behind by the rest of the world if we insist on full FDA approval. This is not going to happen for many months due to the reasons stated above. The reason for pushing for a local EUA is clear—the pandemic is ongoing and there are vulnerable populations where the risk of an unforeseen rare side effect is far outweighed by the benefit of protection. No country can afford to wait for full approval when healthcare workers, elderly and those with chronic illnesses continue to die every day.

The nature of an EUA is that taking the vaccine cannot be compulsory, and those vaccinated will be carefully monitored. There is no truth to the statement that “unproven vaccines will be forced on everyone” since the terms of the EUA are both voluntary and are targeted to specific populations.

Understanding Procurement of Vaccine Supplies

The US and other Western countries committed to purchase vaccines even before clinical trials started. The US even gave financial incentives and grants to drug companies to help them perform the clinical trials.

The US understood early on that drug companies would be reluctant to invest billions of dollars for clinical trials unless they were guaranteed a market for their product. Operation Warp Speed was premised on providing money to accelerate development and/or committing to buy a certain volume of vaccines as long as the vaccine developed passed the minimum standards of efficacy and safety.

Committing to a vaccine even before it has completed the required clinical trials is not unusual and is in fact essential if a country want priority for access. This strategy carries a significant financial risk, but is necessary to reserve a place in line. There are some safeguards like setting a minimum efficacy and a minimum amount of time for safety follow-up, but there are no guarantees of a successful product. A few months ago, no one was certain that any vaccine would work. The US and other countries had already put money down without any idea of when or if any of the vaccines they financed would be useful.

To insist on completion of Phase 3 trials before we negotiate and reserve a supply of vaccines is a losing proposition. It is nearly impossible to reserve a Pfizer or Moderna vaccine shipment because now that everyone knows their vaccines work, the demand has far outstripped the available supply. It’s like preordering a hot Christmas toy—there is risk in putting down money, but if one does not, it is highly unlikely that one can obtain it on the open market during the holiday season.

No reputable doctor will receive or administer a Covid-19 vaccine that has not completed Phase 3 clinical trials with at least a minimum of two months follow-up. It is imperative, however, that the government negotiate with all possible companies in order to reserve a supply in case the product turns out to be effective. Local procurement laws prohibit the government from paying for something that has not yet been delivered, and so a workaround for advance payments needed to be done. This was partially accomplished by the government invoking emergency powers as well as asking for help from the private sector and third parties to provide money to bridge this gap. The private sector stepped up to reserve several million doses of the Astra-Zeneca vaccine, and the Asian Development Bank is helping finance some of the other vaccine deals. 

Vaccines represent our great hope for the future. This is in line with the message of the Christmas season. While our faith guides us toward spiritual salvation, science guides us in understanding and deciding whether a Covid-19 vaccine is the key to our freedom. 

Fake information is a pernicious enemy that will unnecessarily prolong this pandemic and ultimately cost more lives. Let us embrace the coming vaccine for what it really is—a true miracle of science.

 
CLICK HERE TO SIGN-UP
 

YOU MAY ALSO LIKE

["opinion","opinions-and-editorials","opinions-and-editorials"]
[2581196,2637905,2637862,2637844,2636907,2637001,2636925]