The fact that a 16-month-old boy in Florida tested positive for the coronavirus and a few days later, tested negative at a second lab, is problematic, according to a medical professional who believes the positive test was the right one, The Wall Street Journal reported.
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“A false negative is problematic because it tells the patient they don’t have the virus,” said the doctor, Craig Deligdish, an oncologist at Omni Healthcare, a Melbourne, Fla., medical group. Meanwhile, that patient can unwittingly spread it, he said, according to the WSJ report.
According to the Boston Globe, doctors are worried that inaccurate results may give patients a false sense of security, causing them to be lax with their hygiene and social distancing, and possibly spreading more infection. This false sense of security could also place health care workers at higher risk.
Safety testing for vaccines typically leaves much to be desired to begin with, but when it comes to fast-tracked pandemic vaccines, safety testing is accelerated and becomes even more inadequate.
With some health experts believing nearly one in three patients who are infected are getting a negative test result, then inadequate testing looks like it may be the case since plans are already underway to fast-track a COVID-19 vaccine and get it on the market.
Researchers working on a COVID-19 vaccine are foregoing some of the normally required safety testing, and at least one vaccine manufacturer is relying on an entirely novel technique while by-passing traditional animal testing before conducting human clinical trials.
It will still be at least a year or more before the vaccine will be available to the public. But that’s a significantly shorter wait time than the 15 to 20 years it normally takes to bring an experimental vaccine to market.
Fast-tracking vaccines comes with considerable risks. It might be ineffective, which is typically the case for the seasonal influenza vaccine, or it might cause serious side effects, as was the case with the fast-tracked H1N1 swine flu vaccine in 2009. Or, it could even worsen infection rather than prevent it.
The overall effectiveness of the 2018-19 flu vaccine against all influenza virus infection associated with acute respiratory illness (ARI) needing medical attention was a dismal 47% and was an abysmal 8% effective against influenza A (H1N1), which was by far the most common type.
When it comes to cozy business relationships between government and industry, there is nothing like the lucrative one that Congress has encouraged federal health agencies to create with the drug and vaccine industry. One hand washes the other.
In 1992, Congress passed a law accelerating the licensing approvals of new drugs and vaccines. More than half of the FDA’s budget is now funded by the pharmaceutical industry through the fees the government collects that are a direct result of that 1992 legislation.
The Food and Drug Administration Amendments Act of 2007 allows companies developing treatment for neglected or rare pediatric diseases to pay the FDA for a priority review voucher (PRV) to fast-track approval of the drug or vaccine. The PRV has proved to be a windfall for companies producing vaccines. A PRV typically secures fast-track approval in six rather than 10 months.
Under the law, drug companies developing treatments for neglected and rare pediatric diseases can sell their PRVs to other companies, including vaccine manufacturers, for millions of dollars to fast-track licensure of completely different, profitable drugs and vaccines, including the HPV vaccine.