Since the pandemic’s early days, Operation Warp Speed was launched to help create a COVID-19 vaccine safely and as quickly and as possible.
On the 14th of Dec, the Pfizer-BioNTech vaccine was the first approved by the FDA (Food and Drug Administration) for EUA (emergency use authorization), which would allow millions of individuals to get vaccinated.
Despite this breakthrough, there are still some tough questions about the vaccine and the road ahead. We try to provide answers to a few of these questions.
Does the vaccine authorization infer an end to double-blind vaccine trials?
The Pfizer vaccine trial has around 37,000 participants, most of whom are in the US (United States). Over 18,000 received a vaccine, and an equal number of individuals were given a placebo.
Although enough data has been collected for emergency use authorization, many researchers believe that the trials will continue, notably with these initial participants .
This allows for long-term tracking of side effects of the vaccine beyond the introductory monitoring period used for the Food and Drug Administration (FDA) approval.
Although most of the steps for authorization have been expedited, the public should be absolutely sure that none of the scientific strides along the journey have been compromised .
As a result, scientific integrity is transparent, and these vaccine studies will continue to gather ongoing data.
How long will the vaccine be effective?
With the pace at which this vaccine was approved, there’s no exact data on how long this vaccine will be adequate from enrollment to acceptance. The virus was only just noticed at the end of 2019.
Based on Pfizer’s and Moderna’s clinical trials, which both started at the end of July, experts have shown that the vaccines have long-lasting protection, but the actual length of time is still unclear.
However, with the available data, research shows continued protection since the start of the trial. Further monitoring of trial participants in the years and months to come will allow for an understanding of long-term immunity .
How potent will this vaccine be in the general populace?
Although there’s robust protection against COVID-19 after receiving the vaccination, there’s still a remote chance that one could catch the virus after being vaccinated . The vaccine takes time to give protection, and no vaccine is perfect.
The Pfizer vaccine is understood to be 95 percent effective, according to data released by regulators. The Moderna vaccine turns out to be about 94 percent efficient.
But even after receiving these vaccines, it may take multiple weeks for the body to start building immunity after the vaccination. This means that anyone could get sick with the virus just before or even just after obtaining the vaccination.
While only specific groups can get the vaccine now, when will the general public get it?
With an initial restricted supply of the COVID-19 vaccine, only certain groups can be vaccinated.
Based on current projections, healthy individuals under the age of 65 with no medical conditions that put them at more significant risk for COVID-19 complications and who are not in one of the other priority categories (essential worker, healthcare worker, first responder) can probably expect to commence receiving their vaccinations by initial spring, late March through April.
Vaccine manufacturers are working promptly to produce and ship them rapidly. Several companies are working to ensure that this vaccine can arrive at the points of use as safely and quickly as possible.
Very much will depend on any disruptions in the supply chain for the materials required to prepare the vaccine. If there are any interruptions in the materials, that timeline may have differed.
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When will pregnant women be able to be vaccinated?
The COVID-19 vaccine trial that was being developed by several firms didn’t include pregnant women. Historically, vaccine and drug makers tend to be reluctant to include pregnant individuals in initial clinical trials for fear of jeopardizing a pregnancy.
Studies in pregnant women are planned despite the American College of Obstetricians and Gynecologists (ACOG) advocacy for inclusion in the initial trials. For women contemplating becoming pregnant in 2021, should they wait for a vaccine?
Most of the data collected are still new, and pharmaceutical companies didn’t specifically include individuals who were considering becoming pregnant in their clinical trials.
Therefore, there are no human data to suggest vaccine safety in individuals who are planning to become pregnant. As a result, there’s no formal recommendation in the United States for families looking to become pregnant.
Among the participants of phase ii and phase iii clinical trials, several individuals have subsequently become pregnant, and, according to ACOG, these individuals are being followed to collect safety outcomes.
[Read: How Can Pregnant Women Be Safer?]
Can women who are breastfeeding get vaccinated?
With the trials that have been run, data regarding lactating women and the COVID-19 vaccine has not formally been investigated. According to the CDC, individuals who are breastfeeding and are part of one of the prescribed groups to get the COVID-19 vaccine, such as healthcare professionals, may prefer to be vaccinated.
Both the Moderna and Pfizer vaccines are of the mRNA type and thought not to pose a breastfeeding baby’s risk. It is recommended that breastfeeding individuals be vaccinated as the vaccine contents should not be present in the blood and hence not found in the milk.
Should people who have already had COVID-19 be immunized?
The present suggestion advises that those who have already contracted COVID-19 still get the vaccine. While natural infection with the virus provides you some degree of immunity, it does not give you complete protection.
The participants in clinical trials received the COVID-19 vaccine at the end of Jul, and emergency authorization of the vaccine was granted in Dec.
In light of this, it’s unclear how long immunity will last with these vaccines. Participants of the preliminary clinical trials are still being observed, so we only have data since that time.