One week ago, President Trump declared that there could be a COVID-19 vaccine ready by the end of October. And, with nine potential vaccines currently undergoing phase three trials (the final trials that new medicines must undertake before being approved), it seemed as though he could be correct.
However, progress has been stunted because one of the frontrunners of the race in developing a coronavirus vaccine has put a hold on their trial due to serious safety concerns.
A Serious Adverse Reaction
A large phase three trial for a COVID-19 vaccine was being carried out by AstraZeneca and the University of Oxford at dozens of sites across the US. This vaccine has been at the forefront of developments since the race to develop one began several months ago, but concerns were sparked earlier this week when testing was put on hold due to a suspected serious adverse reaction in a participant in the UK.
A serious adverse reaction can refer to symptoms that require hospitalization, life-threatening illness, or death. AstraZeneca, the company behind the vaccine, said that their standard process has triggered a pause to allow for a review of safety data. This action is not uncommon during the testing of potential new medicines, and any unexplained illness is investigated to maintain the integrity of the trails.
The exact nature of the reaction is not known, but the participant in question is expected to recover. As the world eagerly waits for a vaccine, AstraZeneca is said to be reviewing the situation as quickly as possible to avoid any significant impact on the trial’s timeline. However, a source close to the trials said that this development is also impacting other AstraZeneca trials as well as vaccine development being conducted by other manufacturers.
FDA to use ‘Emergency Powers’?
Meanwhile, President Trump is pushing for the Food and Drug Administration (FDA) to fast-track a vaccine without formal approval. The Centers for Disease Control and Prevention (CDC) has advised public health departments in all 50 US states to be ready to distribute a COVID-19 vaccine by 1 November, just two days before the US presidential election on 3 November.
Trumps’s aim to make this happen would require the FDA to use their emergency powers to clear the vaccine before it can be formally approved. This has concerned many experts and policymakers because skipping trials may mean that we see widespread severe adverse reactions in an uncontrolled environment. If that happened, there could potentially be serious health-related consequences for the general public.
Regarding concerns that safety is being ignored to ensure that the vaccine is available before the election, health and human services secretary Alex Azar said in a TV interview, “It has nothing to do with elections. This has to do with delivering safe, effective vaccines to the American people as quickly as possible and saving people’s lives.”
Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, has previously stated that a more realistic timeline for a vaccine would be 2021. However, in an interview on 1 September, he said that a vaccine could be available earlier if the independent Data and Safety Monitoring Board concludes that ongoing clinical trials are yielding largely positive results.
Rolling out the Vaccine
Once a vaccine is ready, the huge logistical task of rolling it out across the country begins. Vaccines would be given first to front line and healthcare workers, other essential workers, and employees working in national security. Other groups pegged to receive the vaccination in the initial rollout are people over 65, Native Americans, racial and ethnic minorities, and people in prisons.
Only around half of Americans have said that they would be willing to get a vaccine for COVID-19, and anti-vaccine protests are raging on around the country. Many US citizens don’t trust the government, which may be due to mixed messaging and a seemingly blase approach to the pandemic.
What Can We do in the Meantime?
As the likelihood grows that a vaccine might take a while longer to produce, it’s important that we continue to take steps to protect ourselves and our communities. Many states are now largely open, but it’s recommended to continue taking care when visiting public places. Implementing social distancing and limiting contact with others wherever possible is also important, as is frequently washing your hands and making sure you have your mask to hand whenever you’re outside your home.