Dr. Scott Gottlieb estimated that a vaccine for the 5-11-year-old age group could be available by Halloween – in a best-case scenario.
COVID-19 is “back” in the news today. Here’s a look at some interesting developments on the pandemic front.
Trick or Treat?
In the midst of the current Delta surge, COVID-19 cases are rising among 5 to 11-year-olds. Parents of these children received a welcome nugget of hope on Sunday when former U.S. Food and Drug Administration (FDA) commissioner Dr. Scott Gottlieb appeared on Face the Nation and estimated that a vaccine for this age group could be available by Halloween – in a best-case scenario. Gottlieb, who is now on the board of Pfizer, said that his prediction is based on the expectation of that company having their data back before the end of September. He stated that Pfizer “could be ready to file within days of having that data.” Following this, he expects the FDA to move quickly, reviewing the data in a matter of weeks as opposed to months, which he interpreted to mean 4-6 weeks. Hence, the Halloween guesstimate. Gottlieb urged parents to speak to their pediatricians to determine the right approach for their children.
Unfortunately, given the 2-week waiting period for the vaccine to take full effect, this wouldn’t clear the way for trick-or-treating. It would, however, be very good news for Thanksgiving gatherings.
Where Did COVID-19 Come From Anyway?
A not-so-new hypothesis – though rooted in questionable scientific methodology and an unlikely timeline – is gaining traction positing that the SARS-CoV-2 virus was in Italy prior to being discovered in Wuhan, China. In a preprint published in early August, researchers reported that they had detected evidence of SARS-CoV-2 genetic material in samples taken from 11 subjects being surveilled for measles and rubella in Italy prior to December 8, the day the first case is thought to have emerged in Wuhan. The authors said the earliest case goes back to late summer 2019.
The paper, which is not the first to suggest the theory, has been widely disseminated in the media, including by Chinese state media. If it has merit, the idea would put the virus on a wildly different boomerang-like trajectory.
There are several potential problems, however. The first stems from the methods the authors took to reach their conclusions. The team, led by Elisabetta Tanzi, a professor at the University of Milan, amplified tiny amounts of RNA or DNA in a sample – an approach that is highly susceptible to contamination and also prone to generating false positives. An early report by Tanzi appears to contradict itself. While the authors claim to have found evidence of SARS-CoV-2 in a boy in northern Italy in November 2019, they also state that the lab was “designated as free from SARS-CoV-2. This, despite claiming to have amplified a sample provided by a local hospital as a control to develop a test. In the current study, the authors do not share what controls were used.
The timeline is also suspect, The researchers constructed a multinational tree, suggesting that the virus still originated in Wuhan before migrating to Italy in October 2019.
“It doesn’t fit anything that we were watching at the time,” said Andrew Rambaut, a molecular evolutionary biologist at the University of Edinburgh.
Michael Worobey, an evolutionary biologist at the University of Arizona, added that it would be like finding an iPhone in a pharaoh’s tomb, meaning that either one would have to rewrite history or consider that one of the archaeologists dropped their phone.
Food for thought.
More Evidence Required for Widespread Booster Shots
A multi-national group of 18 leading scientists is warning against giving COVID-19 booster shots to most fully vaccinated people. In a review published Monday morning in the Lancet, the authors, which include two former FDA officials who recently resigned over the Biden administration’s booster shot plan – said that current evidence isn’t there to support “widespread use of booster vaccination” in the general population. The group cited 93 references.
“Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics,” the authors said.
On August 31, Marion Gruber, director of the FDA’s Office of Vaccines Research & Review (OVRR) and Philip Krause, the division’s deputy director, announced their intentions to depart the agency within the coming months.
They said that the currently approved vaccines were holding up against the Delta variant and cautioned that there could be a significant risk of side effects if boosters were “widely introduced too soon, or too frequently.”
The group, which also included top scientists from the U.K., Mexico, Jamaica, France, Portugal, South Africa and Colombia, warned that these potential additional side effects could reduce vaccine acceptance.
