I’m optimistic about … COVID-19 vaccines (part 2).

Vaccine Approval.

 The approval process for vaccines is arduous and involves the following steps:

  1. Preclinical: Laboratory and animal testing to determine potential use in humans.
  2. IND (Investigational New Drug) Application: Submission of R&D and preclinical data to the FDA for review and initiation of human trials.
  3. Phase 1: Generally, a small trial conducted in 20-100 healthy people to determine safety, dosage, and immune response.
  4. Phase 2: Mid-range trial conducted in several hundred people to assess dose-response and adverse events associated with the vaccine.
  5. Phase 3: Large RCT (Randomized Controlled Trial) involving thousands of people to assess efficacy (does the vaccine work under ideal conditions?) and safety (does the vaccine cause harm?) versus a placebo.
  6. BLA (Biologics Licensing Application): Comprehensive submission of all preclinical and clinical data to the FDA for review. There is no timeline for approval. In emergency situations like the COVID-19 pandemic, approval may be granted under an EUA (Emergency Use Authorization).
  7. Phase 4: Post-approval oversight and ongoing monitoring that may require post-marketing studies to further assess known or potential serious risks. Vaccines are closely monitored using multiple surveillance systems including: VAERS (Vaccine Adverse Event Reporting System), BEST (Biologics Effectiveness and Safety) program, the FDA Sentinel Program, the FDA and CMS (Centers for Medicare & Medicaid Services) partnership program, the V-Safe phone app, and the CDC Vaccine Safety Datalink.

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COVID-19 Update – Remdesivir.

The pharmaceutical landscape for COVID-19 treatments is rapidly changing. Since my post last week on hydroxychloroquine, three new reports have come out regarding the drug’s use: two related to cardiac side-effects, and a separate randomized controlled trial on the drug’s capacity to clear the virus and improve blood markers of infection and inflammation. Continue reading

I’m skeptical about … hydroxychloroquine.

March 21, 2020, Trump tweet: “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains.”

The bully pulpit of the president still carries a lot of weight, and Trump’s repeated touting of the anti-malarial drug hydroxychloroquine for the treatment of COVID-19 provided incentive for FDA officials to approve its use under the Emergency Use Authorization section of the Federal Food, Drug, and Cosmetic Act one week after the above tweet. Continue reading