Quantcast
19.5 C
United States of America
Thursday, August 5, 2021

The FDA and CDC issued an unusual rebuke to the pharmaceutical company hours after it warned of waning immunity from its coronavirus vaccine

Must read

The FDA and CDC issued an unusual rebuke to the pharmaceutical company hours after it warned of waning immunity from its coronavirus vaccine
But as the Biden administration struggles to boost low vaccination rates in Southern states amid a troublesome level of Covid-19 vaccine hesitancy, decisions about safety precautions in schools will be made, as always, at the local level.
Those decisions have already become a hot political topic as fall approaches, with Republican Texas Gov. Greg Abbott, for example, banning mask mandates in public schools earlier this year, while California health officials announced Friday that they would continue to require students and teachers to wear face coverings indoors even though the CDC’s new guidance said vaccinated teachers and students don’t need to wear masks inside school buildings.
The CDC’s new guidance comes when many parents are still anxious about the risks of Covid-19 variants, as well as the many unknowns about what the long-term effects of Covid infections could be in children.
As school districts brace for the uncertainty of another semester with many unvaccinated children, Pfizer sent a jolt of alarm through the country by announcing Thursday that it is seeing waning immunity from its coronavirus vaccine and it will seek emergency use authorization from the US Food and Drug Administration in August for a booster dose. In an unusual rebuke, the FDA and the CDC released a joint statement hours after the Pfizer missive saying boosters were not needed yet, and Biden administration officials sought to amplify that message Friday.
A very small number of children up to age 18 have died from Covid-19 in the US — 391 out of more than 606,000 deaths, according to CDC data. But there is great uneasiness among parents since only children 12 and older are currently eligible to be vaccinated. There have been notable outbreaks at summer camps this year, including infections among more than 125 campers and adults who attended a summer camp run by a South Texas church. And the risk of new variants remains an intense concern in communities with high numbers of unvaccinated people.
Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, voiced those concerns about the lack of study on the long-term effects of Covid-19 in children during an interview on CNN’s “The Lead” Friday afternoon. He noted that the data about children is often presented in terms of deaths and hospitalizations, numbers he acknowledged are “relatively low” in that population.
“We need clarification on the percentage of children who have debilitating effects from Covid, especially neurological effects in the developing brain,” Hotez told CNN’s Pamela Brown. “We need the pediatric neurological societies to really look into this more in depth. … We tend to use very blunt instruments when talking about either adolescents’ or children’s deaths, and only hospitalizations. There are so many more dimensions to Covid than that.”

New confusion about booster shots

This week’s Pfizer announcement not only sparked new confusion about when booster shots might be needed for adults but also created a potential opportunity for anti-vaccine activists who are looking to undermine public confidence in the shots.
Back in April, Pfizer CEO Albert Bourla suggested that “there will be likely a need for a third dose, somewhere between six and 12 months” after the first round. On Thursday, the company confirmed his prediction in a formal statement, citing a recent statement from Israel’s Ministry of Health that said the efficacy of the Pfizer vaccine declined after six months, along with unreleased data from the company’s ongoing studies.
Pfizer offered an important caveat that was mostly lost in the shock of its announcement, confirming that the vaccine’s protection against “severe disease remained high across the full six months.” The drop in efficacy manifested as a rise in symptomatic illness, the company said, while also pointing to the emergence of dangerous new variants as reason to get a jump on authorization for a booster.
But the hazy reasoning behind Pfizer’s declaration, which was delivered without clear clinical evidence of its underlying assertion, was met with the sharp contradictory statement from the leading US regulatory agencies.
“Americans who have been fully vaccinated do not need a booster shot at this time,” the CDC and FDA said in their rare joint statement. “FDA, CDC, and NIH (the National Institutes of Health) are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.”
The message from the government agencies was clear: The decision was not Pfizer’s to make.
“This process takes into account laboratory data, clinical trial data, and cohort data — which can include data from specific pharmaceutical companies, but does not rely on those data exclusively,” they said in the statement.
In an interview with CNN’s Wolf Blitzer on Friday night, Dr. Anthony Fauci, the nation’s leading infectious diseases specialist, disputed the idea that Americans were receiving a “mixed message” and said it is important for them to trust that their government agencies will tell them when and whether they might need a booster shot.
“We respect what the pharmaceutical company is doing, but the American public should take their advice from the CDC and the FDA,” said Fauci, the director of the National Institute of Allergy and Infectious Diseases. “The important bottom line in all of this is that the efficacy (of the vaccine) against severe disease — particularly hospitalization that might lead to death in some individuals — was still really very good.”
White House press secretary Jen Psaki stressed Friday afternoon that the decision about when a booster might be needed is “going to be led by the data and by the science.”
“We wanted to make clear that that is not something that the American people need to plan for at this moment,” Psaki said.
As concerning as Pfizer’s claim might have been to some, the public clash between the pharmaceutical giant and top US government agencies could foreshadow something worse.
Public and private institutions have largely spoken with one voice as the vaccines were developed and distributed, a useful tool for public health leaders working to chip away at hesitance as they pushed forward with this unprecedented mass vaccination campaign.
But signals of a divide between the two could deal a devastating setback to that project, offering fodder to anti-vaccination agitators.
Asked at the briefing whether the administration would push for coordination on these kinds of announcements — as a way of preventing another similar back-and-forth — Psaki appeared to betray some frustration with Pfizer’s actions.
“They are a private-sector company. I can’t speak to the origin or the motivation of their announcement. You’d have to ask them that,” Psaki said. “But the role we can play, from the US government, is to provide accurate information and public health information, which is what we’ve ventured to do last night pretty rapidly in response to the announcement.”

Huge challenge in regional divide over vaccines

As school districts look to the fall semester, Biden’s team is redoubling its efforts to deploy trusted messengers into communities where vaccine uptake is low, but the challenge is monumental given the political polarization in this country and the unfortunate fact that masks and vaccines remain divisive territory.
An analysis by Georgetown University this week underscored the political challenge of changing the mindset of those who remain unvaccinated by showing the huge clusters of unvaccinated people in the Southern United States. An increasing number of studies have demonstrated that vaccine coverage maps bear a striking resemblance to the 2020 election results map — meaning it may be very hard for the Biden administration to shift attitudes toward vaccine acceptance in those regions.
The CDC guidance on schools is likely to become part of that debate, just as it was last year when President Donald Trump was in office.
The CDC stressed Friday that schools should continue using safety precautions, including masking and physical distancing, while encouraging those who are eligible to get vaccinated, such as offering vaccines on site and providing paid sick leave for employees to get vaccinated.
Fully vaccinated teachers and students do not need to wear masks, the guidance said, but the CDC still wants to see unvaccinated children masked indoors and for schools to continue physical distancing if not everyone is vaccinated.
Schools that want to begin phasing out pandemic precautions should do so carefully, the CDC said, by removing them one at a time — if community transmission levels are low — while continuing a robust testing regimen to monitor for increases in spread before removing the next safety measure.
Dr. Megan Ranney, an emergency physician at Rhode Island Hospital and an associate professor at Brown University, noted that she has been a proponent of schools being open even before vaccines were on the scene. But now she is concerned that “the states that have low vaccination rates are also the states that are less likely to put the non-pharmaceutical interventions in place.”
“They’re going to be less likely to say that kids should mask in school,” Ranney said Friday on CNN’s “Inside Politics.” “So they’re going to be setting up their communities, not just for the spread of the virus within the kids, but also within the larger community. Because those kids are then going to spread Covid on to their parents and grandparents and extracurricular school instructors. That’s what worries me even more than whether we can open the schools or not.”

Author: Analysis by Maeve Reston and Gregory Krieg, CNN
Read more here >>> CNN.com – RSS Channel – HP Hero

- Advertisement -
The FDA and CDC issued an unusual rebuke to the pharmaceutical company hours after it warned of waning immunity from its coronavirus vaccine
Newslanes Mediahttps://newslanes.com
Newslanes.com is the leading e-news platform for the latest breaking news of world today. We aggregate and gather popular stories, business news, tech releases and much more. The news repository targets everyone after factual and well-researched information from a dedicated global team of news reporters and editors.
- Advertisement -

More articles

LEAVE A REPLY

Please enter your comment!
Please enter your name here

This site uses Akismet to reduce spam. Learn how your comment data is processed.

- Advertisement -

Latest article