CDC & FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older

Transparency and vaccine safety are top priorities for the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). U.S. government agencies use multiple, complementary safety monitoring systems to help detect possible safety signals for vaccines and other medical countermeasures as early as possible and to facilitate further investigation, as appropriate. Often these safety systems detect signals that could be due to factors other than the vaccine itself.

All signals require further investigation and confirmation from formal epidemiologic studies. When one system detects a signal, the other safety monitoring systems are checked to validate whether the signal represents an actual concern with the vaccine or if it can be determined to be of no clinical relevance.

Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination.

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:

• A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke

• A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine

• The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine

• Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine

• Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines

Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past

, when one of our safety monitoring systems detects a signal. CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting

of the FDA’s Vaccines and Related Biological Products Advisory Committee.

No change in vaccination practice is recommended. CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/bivalent-boosters.html

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NSA begs congress not to cancel 702 Spying…

NSA leader pushes lawmakers to keep key surveillance power

The head of the National Security Agency made his case Thursday for lawmakers to keep a key NSA surveillance power intact ahead of a tough reauthorization battle this year.

The big picture: Section 702 of the Foreign Intelligence Surveillance Act is set to expire at the end of the year, jeopardizing a surveillance authority that allows intelligence agencies to collect warrantless online communications from foreign persons.

The fight over whether to keep Section 702 intact will take up much of Capitol Hill's cybersecurity attention throughout the year.

Driving the news: Gen. Paul Nakasone, the head of the NSA and the U.S. Cyber Command, said during an event Thursday that the surveillance power has allowed the U.S. to stop active terrorist plots, foreign ransomware attacks and planned cyber espionage schemes.

"This authority provides the U.S. government irreplaceable insights, whether we're reporting on cybersecurity threats, counterterrorism threats, or protecting U.S. and allied forces," Nakasone said.

"We have saved lives because of 702," he added.

Why it matters: Nakasone's comments set the stage for the arguments that the intelligence community is likely to make as lawmakers debate the merits of the program throughout the year.

Yes, but: Civil liberties and privacy advocates have long argued that Section 702 sweeps up far too many Americans' electronic communications, such as emails and text messages, when they talk with people in other countries.

Some Republican lawmakers are also likely to argue for either letting 702 expire or limiting its scope as their party grows more critical of the intelligence agencies.

https://www.axios.com/2023/01/13/nsa-leader-plea-key-surveillance-power