Possible Covid-19 Vaccine From Oxford Will Be Presented To Regulators This Year

Professor Andrew Pollard claims there may be enough clinical data from the vaccine’s trial that it can be presented to regulators by the end of 2020.

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The Oxford Vaccine Group has been tirelessly working on various drug treatment/vaccine options for the Covid-19 virus since the pandemic first emerged in early 2020. Now, after extensive trials on their most successful vaccine treatment to date, scientists claim they can prove it’s safe and effective enough to be distributed to the general public. 

The vaccine will have to go through the necessary regulatory process that all new vaccines must endure before public distribution, however, this is the first vaccine to reach this step of the process after completing the other necessary phases of trial testing. Some professors working alongside Pollard believe that the distribution process could take well over a year and the vaccine may not actually be available until winter 2021, however, Pollard is hoping for a more streamlined outcome. 

Pollard believes that while it could potentially take that long, it’s also possible that they “could have the data to put before regulators this year, and then there would be a process that they go through in order to make a full assessment of the data.” While this doesn’t necessarily mean that the vaccine will be approved this year, it’s a major step in the right direction.

“Even with 1,000 people, you’ll have enough data to know whether or not a vaccine works, but that could take years. Having 20,000 people in our trials already means that that period of time will be shorter.”

Pollard originally hoped that their trial would involve 50,000 individuals to get an even larger data pool to work with, however, him and his team quickly learned that the size of the trial wasn’t the main issue, instead, researchers had to focus on the number of positive cases. For this particular vaccine Oxford has trials going on in the UK, Brazil, and South Africa; combined it’s about 20,000 participants of different demographics. 

AstraZeneca is also set to move forward on their own trials in America and will be enrolling 30,000 citizens to do so. So in total there will be around 50,000 individuals receiving the potential Covid-19 vaccine. The participants involved will be participating in what’s known as Phase 3 of the vaccine trial process. 

Phase 3 is thought to be the most important phase, as it’s when the vaccine’s at the point of development where it can be distributed to larger sample size groups for observation. In general with these trials, half of the participants receive the actual vaccine while the other half receives a placebo shot to be the control group; participants aren’t aware of which one they’re getting. The participants will be closely monitored and checked-in with for the next couple of years. 

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“We want to have evidence that the vaccine actually works, including in the US where Donald Trump has said he could seek emergency approval for a vaccine such as this one in October.”

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Emergency use authorizations have already been established in both the US and Europe, and they received these authorizations from vaccine regulators working out of both countries. Recently in the US, the Food and Drug Administration granted emergency use authorization for Covid-19 plasma therapy. This therapy involves taking plasma from the blood of individuals who have recovered from the coronavirus and giving it to patients currently suffering with the virus. This treatment has been proven to accelerate the rate of recovery in certain patients. 

The process of receiving this authorization is still extensive and has to be carefully conducted by regulators to ensure that the existing data on whatever’s trying to get approved is valid. Pollard compared it to the process of collecting information on vaccines for their clinical trials; you need to have a lot of backed-up evidence that proves it can move onto the next phase of development. 

“For our suite of trials that we’re running from Oxford, we would expect to first of all have safety data and then evidence that the vaccine actually works, and before anything were to progress from there and of course it’d be AstraZeneca who would then take that forward to regulators.”

AstraZeneca is the pharmaceutical company that partnered with Oxford for the Covid-19 vaccine development. As a company, they’re doing a separate trial for a new drug that they also believe could help prevent and treat the coronavirus; volunteers are already receiving doses of this potential treatment. The drug is known as AZD7442 and is a combination of two viral antibodies. 

The goal from both groups is always safety first. Effectiveness is obviously a crucial aspect to any vaccine, however, there’s no way for a vaccine to be effective if it isn’t safe enough to exist in the human body. For now, Oxford and AstraZeneca are confident in their ability to develop a Covid-19 vaccine that will work, it’s just more a matter of when.