What Milestones Does a Vaccine Need to Hit Before Approval?

The typical vaccine goes through six general stages of development before receiving approval for distribution.

1. The exploratory stage looks at the viability of a vaccine. Some diseases would not respond well to this treatment option, so the first effort must be to see if it would be effective.

2. The preclinical stage begins the developmental process so that the actual vaccine gets created. It includes the initial manufacturing to produce an item that is ready for trial.

3. Clinical development is a three-phase process that must get completed before governments can review and approve a vaccine. The first one involves small groups of individuals who receive the trial vaccination. If those results are encouraging, the second phase expands the clinical study to include people with specific characteristics. The final stage has the vaccine given to thousands of people to test for safety and efficacy.

4. Once a vaccine proves to be safe and effective, government agencies send it through a regulatory review process. The goal of this step is to review the evidence of safety and efficacy to ensure the shot doesn’t cause more harm than good. It receives approval only after this independent evaluation.

5. The manufacturing process begins after a vaccine receives approval. Some companies follow an “at risk” policy that has them produce doses before receiving authorization so that the item can get immediately distributed to the general public. If a denial happens instead, all of the vaccinations would need to be thrown away.

6. The final milestone involves quality control. The goal is to ensure that the vaccine can be as helpful as possible without increasing the risk of additional health problems.

The FDA Requires Specific Information for Vaccines

Sponsors of a new vaccine in the United States must follow a multi-step approval process that includes a new drug application, pre-licensure clinical trials, and a biologics license application. The government inspects the manufacturing facility before issuing an approval.

A presentation of findings to the Vaccines and Related Biological Products Advisory Committee is also mandatory.

The FDA also requires usability testing of the product labeling. Manufacturers can be required to provide the results of their tests for purity, potency, and safety, or be required to submit to third-party examination. 

All of this is important for the average citizen, but for those who work in the medical field, make sure to note the information here so you can pass it along. If you want more in depth information on the topic, check out our patient safety news sources you should be following.

Why States Released Prisoners Early During COVID-19 Pandemic

COVID-19 is exceptionally contagious, especially by the precedent set by other coronavirus infections. This reason is why doctors and scientists recommend keeping six feet of social distance between people whenever flare-ups occur.

Some places have very little room to provide social distancing measures. Jails and prisons in the United States were already overcrowded before the pandemic. Officials decided that the safest way to limit the infection potential was to release some non-violent prisoners early.

At-Risk Inmates Were the First to Gain Release

Prisoners do not have the option to take products from brands like Argentyn 23, Sovereign Silver, or Natural Path Silver Wings to support their health. Trying to boost the immune system when eating prison food and being in close confinement with others turned out to be an impossible task.

During the first couple of weeks of the pandemic in New York City, a cluster of cases around the Rikers Island complex had over 450 people test positive for the new coronavirus.

Illinois experienced a similar issue with a cluster around the Cook County jail in Chicago.

Once the virus arrives in a jail or prison, it spreads like wildfire because the crowded conditions don’t give people a place to protect themselves. Even Attorney General William Barr ordered at-risk, non-violent inmates who posed a minimal risk of recidivism to serve the remainder of their sentence in home confinement.

Is it Time to Rethink the Prison System?

Hygiene is not well-practiced at many jails and prisons in the United States because of other risk factors. Most institutions do not permit hand sanitizer because it can get used to make alcoholic drinks in cells.

Facilities don’t provide soap to prisoners or inmates either. It is not unusual for a charge of $1 to get instituted for a single bar, which is a significant cost for people making less than that per hour. 

The boldest measures to protect prisoners came from the state of California. The government there plans to release up to 3,500 non-violent inmates in direct response to the COVID-19 pandemic. Prisons aren’t taking inmates from county jails there anymore either as a way to free up more space.

COVID-19 doesn’t care if you are a law enforcement officer or you break the law. It doesn’t care about skin color, wealth, or what job you have. States released prisoners early because it was the best way to reduce the threat of infection.

Why PG&E Shut Off Power in California to Prevent Fires

The Pacific Gas and Electric Company is a large electric provider for northern California. The utility began to shut off the power to over 800,000 customers in early October to prevent power lines from sparking potential wildfires.

Utilities count each account as a customer, including residential and business locations. That means the number of people impacted is more than 1 million. 

This action was taken as a public safety measure that the company implemented over two phases. It impacted businesses and residences in high-risk areas over 34 counties. Some of the outages lasted for days.

It wasn’t just rural areas that felt the impacts of these blackouts. Parts of Oakland, San Jose, and Berkeley were part of PG&E’s plans.

PG&E Urged Customers to Stock Up on Supplies

Officials from the utility said that there would be no compensation given to companies for lost profits or homeowners who lose food due to spoilage.

The reason for this extreme measure is that PG&E acknowledged in 2018 that its equipment was likely responsible for the devastating Camp Fire. That event destroyed thousands of structures, killed 85 people, and is the most destructive and deadliest fire in the history of California.

PG&E is the largest electricity utility. It filed for bankruptcy protection in January because it faced an estimated $30 billion in wildfire liabilities. That figure was cut by two-thirds with a 2019 filing with securities regulators in May, but the number was still higher than $10 billion.

Even if the shutoff is a good thing that can prevent wildfires, customers are going to find themselves managing new expenses one way or another. Businesses would need to purchase a backup generator that could operate to continue serving customers. Residential customers would need to stock non-perishable items more often with their grocery runs or use a generator to prevent losses.

Are Public Safety Shutoffs Necessary?

Weather events in California can create wildfire triggers in a variety of ways. Strong Santa Ana winds or onshore flows can create gusts that rival hurricane-strength winds. Having utility equipment spark during these incidents can quickly cause a fire to burn when conditions are arid.

PG&E is not the only utility in California to contemplate safety shutoffs because of the weather events that happen during the late summer and early fall. Southern California Edison announced that it was also working on plans that would shut off electricity to over 106,000 customers in parts of eight counties – including the Los Angeles area.

The utility even employs a meteorologist to help them plan for these challenging weather events that might require the power to be shut off to protect structures. 

Turning off the power is always a difficult decision to make. Communities rely on electricity to manage their homes, employment, and more. 

It is an action that becomes a critical balancing act. Having access to power is worthless if it sparks a fire that burns down a home or business. Customers can lose their business without electricity, which might cause them to miss their mortgage payment.

Most customers only have 24 hour notice before a public safety shutoff occurs.