What are vaccine Regulatory Protocols outside a COVID-19 Pandemic? With Susan F. Langlois.

Susan Langlois started her career in 1972 as a lab technologist at Cana Laboratories. • 2:50

Langlois’ expertise spans from biologicals to medical devices in the pharmaceutical industry. • 3:10

She transitioned to regulatory affairs in 1976, overseeing compliance with new regulations. • 3:42

Langlois retired as the Director of Regulatory Affairs at Cana Laboratories after 20 years. • 4:16

She continued her regulatory work with startup biologic companies post-retirement. • 4:58

Her vast experience includes working with biologic companies on regulatory affairs, clinical trials, and quality control. • 5:33

Langlois’ highlight was her involvement in the approval process of BCG vaccine for therapeutic use. • 6:23

Langlois worked on getting the BCG vaccine approved for therapeutic use in bladder cancer. • 6:33

She was instrumental in the approval of BCG vaccine for bladder cancer treatment in Canada and the U.S. • 7:06

Regulations for biologics and vaccines were established in the 1970s to ensure safety for healthy recipients. • 9:26

Vaccines are given to healthy individuals to prevent diseases, unlike drugs for treating the sick. • 10:04

Research is required to determine the need for a vaccine and understand the disease before production. • 13:09

Testing in animals for safety and efficacy is a crucial step in vaccine development. • 13:48

Vaccine development process involves preclinical studies, safety studies, effectiveness studies, and manufacturing consistency checks. • 13:55

Regulatory process includes submitting data to regulators, conducting safety and effectiveness studies, and obtaining establishment licenses. • 14:02

Phase one focuses on safety, phase two on effectiveness, and phase three on efficacy through placebo-controlled studies. • 14:10

Scaling up production requires demonstrating consistency in manufacturing and passing regulatory inspections. • 16:22

Postmarketing strategies, labeling, and advertising also need regulatory approval before vaccine launch. • 17:06

Standard vaccine development process takes around 10 years due to rigorous regulatory requirements and testing. • 17:23

Regulations allow for streamlining processes for unique products targeting unmet medical needs. • 18:09

Staggering phases can be done in emergencies to accelerate vaccine development while meeting regulatory standards. • 18:54

All steps in the regulatory process are essential for ensuring the safety and efficacy of vaccines before approval. • 19:06

Emergency use approval process in the US and Canad. • 19:33

US FDA process for emergency use release. • 20:30

Regulators prioritize safety and data availabilit. • 20:30

Companies must meet safety criteria for approva. • 21:11

Interim order in Canada with one-year expir. • 21:57

Expedited submission process for emergency approval. • 22:38

Priority reviews for COVID-related products worldwid. • 24:49

No preferential treatment for companies in approval proces. • 25:08

Regulations amended for fast-track submission. • 25:59

mRNA technology allowed quicker vaccine productio. • 26:48

Regulators evaluate data for safety profile and risk-benefi. • 27:14

FDA protects interim data as intellectual propert. • 30:09

Companies redact proprietary information before data releas. • 31:04

Requests for data under Freedom of Information Act are processed chronologicall. • 31:41

Approval process for full data release may take up to a year or mor. • 32:07

Regulators struggle to explain complex processes to the general public. • 32:16

External contractors often manage clinical trials for pharmaceutical companies. • 34:09

Pharmaceutical companies follow regulatory guidelines to expedite vaccine production. • 36:23

Regulators request minimum data for initial approval with a commitment to gather more over time. • 38:07

Safety monitoring systems rely on physician-reported adverse events related to vaccinations. • 38:30

Public health agencies play a role in monitoring signals of adverse events beyond initial surveillance. • 40:05

Long-term effects beyond 28 days post-vaccination may not be captured by current surveillance systems. • 41:25

Government and medical authorities should ensure transparency in communicating known and unknown risks of vaccines. • 43:00

Concerns exist about the lack of long-term safety data for emergency-released vaccines. • 43:14

Individuals have the right to accept or reject vaccines under emergency use authorization. • 43:36

Regulations mandate informing individuals of known risks and benefits of emergency vaccines. • 43:50

Data gaps exist in certain populations like pregnant or immune-compromised individuals. • 44:04

Pharmaceutical companies publish monographs detailing available data on vaccines. • 44:11

Concerns about lack of informed consent for vaccine recipient. • 44:50

Regulators and companies provide information, but politicians make mandate decision. • 45:15

Responsibility for vaccine mandate decisions unclea. • 46:45

Regulators ensure safety but may not challenge government mandate. • 49:00

Definition of ‘safe’ varies and may not imply zero risk. • 49:25

Government repeats safety claims without ensuring informed consen. • 50:04

Lack of monitoring for informed consent in vaccine administratio. • 50:31

Government push for vaccination without complete data may harm public healt. • 50:36

Risk-benefit assessment varies based on health profiles and comorbidities. • 50:55

Individuals need to make decisions on vaccine risk-benefit based on their health status. • 52:01

Mass vaccination aims for herd immunity but may not always be effective. • 53:14

Regulatory responsibility includes ongoing safety and efficacy reviews of vaccines. • 54:38

Companies may need to adjust vaccines based on efficacy and safety signals. • 55:10

Changes to vaccines require additional approval processes and clinical trials. • 55:54

Vaccine efficacy is not just about antibody response but also about disease spread prevention. • 56:13

Clinical trials need to consider easy-to-demonstrate endpoints for positive outcomes. • 56:43

Vaccines aimed at reducing hospitalizations and deaths, not infection spread. • 56:55

Lack of evidence demonstrating vaccines reduce infection spread. • 57:01

Shift from lockdowns for vulnerable to herd immunity strategy questioned. • 57:52

Vaccines initially targeted high-risk individuals, then expanded to younger age groups. • 58:06

Monitoring based on positive PCR tests, not disease symptoms. • 1:00:25

Ethical dilemma in distributing boosters to children while vulnerable populations lack vaccines. • 1:02:09

Importance of boosting for individuals with compromised immune systems. • 1:02:51

Limited long-term studies on vaccine efficacy and duration of antibodies. • 1:03:26

Public health is responsible for monitoring all-cause mortality and adverse effects post-vaccine administration. • 1:03:37

Long-term studies are necessary to track antibody levels and vaccine efficacy over time. • 1:03:43

Ethical considerations may lead to offering vaccines to placebo groups post-trial. • 1:04:21

All-cause mortality is typically monitored during clinical trials, with government oversight post-trial. • 1:06:00

Public health agencies are responsible for monitoring trends in all-cause mortality and adverse effects post-vaccine introduction. • 1:09:24

Vaccine adverse events are reported to companies and governments for monitoring. • 1:09:43

Public health monitors signals of adverse events post-vaccination over time. • 1:10:01

COVID-19 may trigger autoimmune responses, impacting severe disease outcomes. • 1:10:27

Vaccines aim to prevent severe disease in high-risk individuals with comorbidities. • 1:12:54

Challenges exist in rebuilding trust in pharmaceutical industry and public health. • 1:13:32

Pharmaceutical companies faced criticism for vaccine efficacy amidst evolving virus strains. • 1:14:07

Clear messaging from governments is crucial to address public confusion on vaccine purpose. • 1:15:05

Mention of the upcoming interview and wishing a great evenin. • 1:15:39

Expressing gratitud. • 1:15:51

Music playing in the backgroun. • 1:16:24

Music continue. • 1:17:17