CDC will withdraw request for Emergency Use Authorization Real-Time RT-PCR Diagnostic Panel
SAN LUIS OBISPO COUNTY — After introducing the “California Roars Back” plan, a part of the $75 billion budget surplus announced back in May, followed by hosting several “Vax for the Win” campaigns throughout June and July that offered prizes, trips, and cash winnings of $1.5 million per person for a total of $15 million. Along with a massive push for Californians to return to living life, Governor Gavin Newsom changed his tune on Tuesday and stated that now “We’re experiencing a pandemic of the unvaccinated.”
Newsom’s statement followed a press conference held at Kaiser Permanente Hospital in Oakland on Tuesday, Jul. 27. During the conference, it was announced that the State of California would require all state workers, workers in health care, and high-risk congregate settings to either show proof of full vaccination or be tested at least once per week (twice as a standard according to Newsom). In addition, Newsom encouraged all local government and other employers to adopt a similar protocol.
“We are now dealing with a pandemic of the unvaccinated, and it’s going to take renewed efforts to protect Californians from the dangerous Delta variant,” Newsom said. “As the state’s largest employer, we are leading by example and requiring all state and health care workers to show proof of vaccination or be tested regularly, and we are encouraging local governments and businesses to do the same. Vaccines are safe— they protect our family, those who truly can’t get vaccinated, our children, and our economy. Vaccines are the way we end this pandemic.”
As stated, unvaccinated workers will be subject to at least one weekly COVID-19 test and will be required to wear appropriate PPE. This requirement also applies to high-risk congregate settings like adult and senior residential facilities, homeless shelters, and jails.
The new policy for state workers will take effect on Aug. 2, and testing will be phased over the next few weeks. The new policy for health care workers and congregate facilities will take effect on Aug. 9, and health care facilities will have until Aug. 23 to come into full compliance.
PCR COVID-19 Testing
On Jun. 10, the U.S. Food and Drug Administration (FDA) warned the public to stop using the Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA explained they have significant concerns that the performance of the test has not been adequately established, presenting a risk to health.
In addition, labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. Finally, the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law. The FDA has identified this recall as a Class I recall, which is the most serious type of recall.
Then on Jul. 21, the Centers for Disease Control (CDC) announced that after Dec. 31 of this year, the CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. The assay was first introduced in February 2020 for the detection of SARS-CoV-2 only.
According to the CDC, the PCR test that has been used solely in San Luis Obispo County and nationally is inaccurate and could potentially risk false results. Therefore, they encourage laboratories to consider adopting a multiplexed method that can facilitate the detection and differentiation of SARS-CoV-2 and influenza viruses.
In May, after several reports were released regarding the inaccuracy of the PCR test, we asked the San Luis Obispo County Department of Public Health about the COVID testing and being able to tell the difference between COVID and influenza. Their response was, “In its own testing efforts at the Public Health Lab and those being conducted at our community testing locations, the County of SLO continues to utilize PCR testing now, at the same thresholds we have used throughout the pandemic…SLO County has identified PCR testing as a best practice and has therefore stayed with that method. This is also the method used for all confirmed positive cases logged in CalRedie, the state’s communicable disease reporting system. The County has also continued to test for influenza throughout the pandemic. However, we have seen very little influenza in comparison to COVID this flu season.”
Along with the CDC’s information, it was also confirmed that the current testing for COVID-19 can not detect different strains such as the Delta variant.
It has been reported that the COVID Delta Variant is what is causing the new outbreaks and hospitalizations to spike even though studies show that it is known to be more transmissible however not deadly.
San Luis Obispo County Health Officials reported that the 129 new cases of COVID-19 confirmed in San Luis Obispo County during the week of Jul. 19, nine were caused by the Delta variant.
According to a report released by the CDC on Jul. 9, the SARS-CoV-2 B.1.617.2 (Delta) variant emerged in India and is currently widespread. Evidence suggests that it is potentially more transmissible than other variants; however, not more deadly.
Research shows that most viruses multiply into other variants.
According to the CDC, viruses constantly change through mutation, and new variants of a virus are expected to occur. Sometimes new variants emerge and then disappear. Other times, new variants persist. Multiple variants of the virus that causes COVID-19 have been documented in the United States and globally throughout the last year.
Scientists monitor these changes, including changes to the spikes on the surface of the virus. By carefully studying viruses, scientists can learn how changes to the virus might affect how it spreads and estimate how sick people will get from it.
Since the SARS-CoV-2 is still so new and research and testing are still being done, all cases are the current case studies at this point.
The CDC states if you think about a virus as a tree growing and branching out, each branch on the tree is slightly different than the others. By comparing the branches, scientists can label them according to the differences. These small differences, or variants, have been studied and identified since the beginning of COVID.
Some variations allow the virus to spread more easily or make it resistant to treatments or vaccines. Those variants will be monitored more carefully.
Because not all cases are sequenced to determine their strain, officials say the actual number of Delta variant cases could be higher. The Delta variant now represents more than 49 percent of cases sequenced in California, and according to the CDC, that is to be expected.
“The Delta variant spreads more quickly and easily than other strains of COVID-19, but we each have the power to stop its spread here in SLO County,” said Dr. Penny Borenstein, County Health Officer.
The CDC is monitoring multiple variants; currently, there are four notable variants in the United States:
B.1.1.7 (Alpha): This variant was first detected in the United States in December 2020. It was initially detected in the United Kingdom.
B.1.351 (Beta): This variant was first detected in the United States at the end of January 2021. It was initially detected in South Africa in December 2020.
P.1 (Gamma): This variant was first detected in the United States in January 2021. P.1 was initially identified in travelers from Brazil, who were tested during routine screening at an airport in Japan in early January.
B.1.617.2 (Delta): This variant was first detected in the United States in March 2021. It was initially identified in India in December 2020.
These variants seem to spread more easily and quickly than other variants, which may lead to more cases of COVID-19.
The County stated that five additional cases of the Delta variant have been identified over the last week of July and reported that only a small percent of COVID-19 cases are sequenced to determine their strain. Officials say the actual number of Delta variant is higher.
It has yet to be confirmed how the County is testing for the Delta variant and COVID since the CDC released the information regarding the current PCR testing for COVID-19 can not detect different strains such as the Delta variant, and the results from such test are inaccurate.
Currently, the three COVID-19 vaccinations in the U.S. are presented as safe and effective and still under emergency orders from the FDA.
The CDC states that the COVID-19 vaccinations will help protect from getting COVID-19, however as the current studies continue, reports show vaccinated individuals can still contract the virus.
Currently, the FDA has granted emergency use of three COVID-19 vaccines.
On Dec. 11, 2020, Pfizer-BioNTech became the first COVID-19 vaccine to receive a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) after the company reported positive clinical trial data included news that the vaccine was up to 95 percent effective at preventing symptomatic disease.
In June, the FDA announced it will place a warning on the Pfizer-BioNTech mRNA vaccines regarding a “likely association” between the Pfizer and Moderna vaccines and reported cases of heart inflammation in young adults.
This inflammation may occur in the heart muscle (myocarditis) or in the outer lining of the heart (pericarditis) and is considered important but uncommon—arising in about 12.6 cases per million-second doses administered.
The inflammation, in most cases, gets better on its own without medical intervention.
Current Status: Emergency use in the U.S.; authorized for use in the European Union (under the name Comirnaty).
The Moderna’s vaccine was the second one authorized for emergency use in the U.S.—it received FDA EUA on Dec. 18, 2020, about a week after the Pfizer vaccine. Moderna is also an mRNA vaccine, using the same technology as the Pfizer-BioNTech one and with a similarly high efficacy at preventing symptomatic disease.
As with Pfizer, the FDA announced in June it will place a warning label on the mRNA vaccines regarding a “likely association” between the Pfizer and Moderna vaccines and reported cases of heart inflammation in young adults.
This inflammation may occur in the heart muscle (myocarditis) or in the outer lining of the heart (pericarditis) and is considered important but uncommon—arising in about 12.6 cases per million-second doses administered. The inflammation, in most cases, gets better on its own without medical intervention.
Current Status: Emergency use in the U.S.; authorized for use in the European Union.
On Feb. 27, the FDA granted emergency use approval for a different type of vaccine, called a carrier, or virus vector, vaccine manufactured by Johnson & Johnson.
An analysis released by the FDA in late February showed that the vaccine might reduce the spread of the virus by vaccinated people.
The FDA has attached two warnings to the Johnson & Johnson vaccine. In July, it attached a warning after rare cases of the neurological disorder Guillain-Barré syndrome were reported in a small number of vaccination recipients. Most of the cases occurred within 42 days after vaccination.
In April, the FDA added a warning label after ending a pause on the vaccine it had recommended “out of an abundance of caution” over an uncommon but potentially serious blood clotting disorder occurred in a small number of recipients.
Current Status: Emergency use in the U.S.; authorized for use in the European Union (under the name Janssen).
For more information on vaccinations, visit fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines or speak to a medical physician.