As new cases of COVID-19 are declining, they worry the data will not meet the hurdles to prove effectiveness
BY STACEY LENNOX MAY 26, 2020 2:50 PM EST
A COVID-19 vaccine developed by Oxford University has generated significant interest. Both the United States and the United Kingdom have ordered large numbers of doses in anticipation of successful human trials. The development cycle for this particular vaccine was shortened because it has already been tested in primates with good results.
President Trump announced Operation Warp Speed, which is aimed at expediting the development and approval of an effective vaccine. This includes upending the traditional production of them. Top vaccine candidates will be manufactured in advance of demonstrating effectiveness so they will be available more quickly.
The Oxford vaccine is one of these candidates and AstraZeneca has struck a deal to produce the vaccine in advance of the conclusion of the human trial. This effort has been backed by $1 billion in U.S. taxpayer money. The goal is to produce 300 million doses by November of 2020.
Not Enough COVID-19
However, Oxford researchers are now warning of an obstacle in the trial process. As new cases of COVID-19 are declining, they worry the data will not meet the hurdles to prove effectiveness. They are now placing the odds of a successful trial at 50%. Professor Adrian Hill is sounding the alarm:
The stakes could hardly be higher. If proven effective, the ZD1222 vaccine would allow people to leave their homes and go back to work, and the shattered global economy to rebuild. But Hill, director of the university’s Jenner Institute, revealed his team now faced a major problem, throwing the September deadline into doubt.
“It is a race, yes. But it’s not a race against the other guys. It’s a race against the virus disappearing, and against time,” he said. “At the moment, there’s a 50 per cent chance that we get no result at all.”
“It is a race, yes. But it’s not a race against the other guys. It’s a race against the virus disappearing, and against time,” he said. “At the moment, there’s a 50 per cent chance that we get no result at all.”
The professor went on to explain that the trial has recruited 10,000 individuals to take the vaccine. He would expect fewer than 50 to contract COVID-19. If fewer than 20 do, Hill says the results will be useless, putting the trial in jeopardy.
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“We’re in the bizarre position of wanting COVID to stay, at least for a little while. But cases are declining.”
Bizarre no doubt, given we were all assured cases would explode as lockdown restrictions were lifted.
The Vaccine Conundrum
This also places residents in some areas of the United States in quite a conundrum. State and local leaders like Mayor Eric Garcetti of Los Angeles and Governor Tom Wolfe of Pennsylvania have said that their citizens cannot return to normal until we have an effective vaccine.
However, according to Professor Hill, we can’t have an effective vaccine unless the virus is spreading at a rate sufficient to infect a statistically significant portion of the test group. It appears we have slowed the spread to such a degree it may deprive us of the vaccine so many are desperately relying on.
Protect the Vulnerable
This is just another reason to loosen lockdown restrictions. In order to test vaccines, the virus needs to circulate. In order for it to circulate people need to be moving around in public. Clearly to get to this point quickly and safely a few things need to happen. This approach should be bolstered by the CDC’s mortality data revisions.
As our health experts have often said, we need to learn to do two things at once. The data shows COVID-19 is most severe in the elderly with pre-existing conditions. Data shows the experience in nursing homes and assisted living facilities is particularly devastating. The public health system must figure out how to scrupulously protect these residents through aggressive sentinel testing and protective measures.
Let COVID-19 Circulate
The virus is least likely to be severe and result in death for people under 50. This is the vast majority of the school and working-age population. Let these people get back to their normal lives taking care to advise those with pre-existing conditions associated with severe or fatal outcomes on how they can protect themselves.
Doctors and clinicians should focus their efforts on information sharing and educating the public on symptoms and treatments aimed at mitigating the most serious disease in the under-50 cohort. There is increasing evidence this is due to an immune system overreaction called a cytokine storm.
Treatment protocols for this condition, such as the one developed by the ICU team at Cedars Sinai Providence, should be widely shared and refined. The FDA should be giving Emergency Use Authorizations for the drugs involved in this treatment as well as the antivirals and other drugs it has been applied to.
Finally, silent hypoxia, or lack of oxygen in the blood, seems to be an early indicator of severe disease in COVID-19. Patients who test positive for the virus should be encouraged to purchase or be loaned a pulse oximeter to continuously monitor this level and given instructions on what level indicates they should seek medical attention immediately.
The idea of herd immunity appears harder to obtain than originally thought given the original infection rate or R0 that was calculated. Sweden, which chose to pursue this model, only has an antibody rate of 7.3% in Stockholm as of the end of April. This is well below the expectation of 60% forecasted originally. This information also presents a hurdle to vaccine development. It is spreading more slowly than assumed.
Allowing the virus to circulate among the population least likely to suffer fatal outcomes is critical to the successful development of a vaccine. A successful vaccine, should one be developed, will allow our high-risk population to confidently return to a normal life. If we don’t move to do this quickly and safely, we only delay the development of the best preventative tool we have.
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