COVID-19 Vaccine, The start of the end
With COVID-19 cases rising each day, there is a need for a vaccine that can help bring herd immunity and stop the spread of the virus.
There is currently no Food and Drug Administration-approved vaccine.
However, a German company, BioNTech SE, announced on Nov. 9 that they got results representing 90% efficiency for a COVID-19 vaccine in phase three trials.
This doesn’t mean that they are ready to release an official vaccine yet.
Pfizer, a collaborator with BioNTech, explains, “We cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.”
This new information is, however, one step closer to providing relief from the ongoing global pandemic.
Another operation, known as Operation Warp Speed, which originated from the Trump administration and established on May 15, has also been working towards a progressive solution.
According to the U.S. Department of Health & Human Services, HHS, their website states that the main goal of this operation is to produce and release 300 million doses of vaccines that are proven to be safe and effective by January 2021.
After an Operation Warp Speed briefing that took place on Oct. 9, Paul Mango, the Deputy Chief of Staff for Policy at HHS, confirmed that the operation is on track to have a vaccine by the end of the year.
However, it is only on track for 100 million doses.
Even though the operation will be producing less than half the number of vaccines that were originally anticipated, Mango also said, “We are still on track to have several hundred million more on the order of somewhere between 600 million and 700 million total by the March to April timeframe of 2021.”
In order to meet the January 2021 goal however, Alison Hunt, a press officer for the FDA, said “to receive FDA approval, a coronavirus vaccine must be at least 50% effective.”
It is unclear how close Operation Warp Speed is to meeting that 50% effective requirement.
Meeting those requirements isn’t the only issue. Even with the reassurance of an effective and safe vaccine from medical professionals within the operation, along with BioNTech releasing their 90% efficiency results, some people are still uneasy about receiving the vaccine once it is released.
Some reasons for not wanting to receive the vaccine could include mistrust of science, skepticism of its safety or simply thinking it isn’t worth the trouble.
These types of people, typically known as “anti-vaxxers,” have others worried and some people angry that it could prevent herd immunity.
According to, Twitter user Eric Viau, “An anti-vaxxer is like a person who refuses to isolate. They benefit from everyone following the rules, yet they are a menace to the overall population.”
It is inevitable that some people will refuse the vaccine, but according to The Atlantic, it’s not something to worry about when it comes to preventing herd immunity.
COVID-19, according to the Atlantic article, is not nearly as contagious as the measles. Therefore “the country would achieve herd immunity even if a sizable minority of Americans refused to vaccinate themselves against COVID-19.”
With the election also being a hot topic in the news, questions have emerged as to how much influence politics has on determining when the vaccine could or should be released.
Some of these questions were brought to the attention of Moncef Slaoui, the leading scientist and appointed key adviser over the operation.
According to Science Magazine, Slaoui spoke to ScienceInsider regarding these questions and they reported “Slaoui insisted he won’t be swayed by political pressures to rush an unsafe or ineffective vaccine, and that science will carry the day—or he’ll quit.”
The FDA has also made it clear that this vaccine is taking the time for safety and effectiveness and has no correlation with politics.
Stephen M. Hahn, FDA Commissioner, said on the FDA website “We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”
Aside from politics, there is a possible way for a COVID-19 vaccine to be released sooner than planned. This solution is to submit a request for an Emergency Use Authorization or EUA.
According to USA Today, the EUA law originated in 2001 after the 9/11 terrorist attack. It was created for the sole purpose of ensuring that during public health emergencies, such as a global pandemic, medical products and medicines could be made available before being approved by the FDA.
Although an EUA could be beneficial and has been a topic of conversation within Operation Warp Speed, Natalie Baldassarre, a Secretary for Public Affairs for the HHS, confirmed that the COVID-19 vaccine currently doesn’t match the criteria listed under the Federal Drug Act and cannot be issued an EUA at this time.
However, Stat News reported on Oct. 29 that “the company now projects that it could apply to the FDA for an emergency use authorization for the vaccine in mid-November.”
Either way, when the vaccine is finally released, ABC News said that there is already a drafted plan, at least for Utah, as to who it will be available to first.
The first wave of doses will be administered to health care personnel most at risk; following will be “LCTF residents” which includes those in a nursing home or assisted living.
The second wave of doses will be reserved for first responders, doctors’ offices and public health clinics.
The last wave will then allow for distribution of the vaccine to the general public, assuming there are enough doses to meet the demand at that point.
With Operation Warp Speed being funded for nearly $10 billion by the federal government, Alex Azar, a writer for Fox Business, said it is all worth it.
Azar said, “This is almost never done in drug development because it would make so little business sense to invest in making a product that you may never use. But, this step has the chance to save huge numbers of lives.”