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Member since: 2001
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Not Just Bikes: Suburbs that don't Suck - Streetcar Suburbs (Riverdale, Toronto)


4 Myths About What It Means For A Vaccine To Be 'FDA Approved'

Myth: If COVID-19 vaccines aren’t (yet) FDA approved, they aren’t safe

While there are important distinctions between FDA approval and emergency use authorization, those words may be thought of interchangeably in at least one way: both mean the FDA considers the COVID-19 vaccines “safe and effective” for the groups indicated.

“In this case, both ‘authorized’ and ‘approved’ are flexible terms that basically mean the same thing in terms of quality and the high standards the FDA sets forth,” said Dr. Arnold Monto, a professor of epidemiology and global public health at the University of Michigan. “The FDA did not lessen the standards for anything, including the amount of time that must lapse, before an application for ‘FDA approval’ could be considered.”

To that end, the FDA spokesperson also left no room for doubt regarding the safety of the vaccines: “The FDA can assure the public and medical community that we have conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information for every vaccine authorized” and that “efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process.”

“With over 120 million people already vaccinated,” Bates said, “this is one of the largest field tests of a vaccine ever conducted, and this vaccine has so far been shown to be as safe and effective as the many medications and vaccines that have been fully approved.”


May we please stop it with the FDA full approval excuse?

We should get more aggressive with the anti-vaxxers.

Unless you have a solid medical reason for not getting the vaccine or you're under the age of 12, then there's no reason why you should not get the vaccine. I would propose that all students, over the age of 12, get the vaccine before they're allowed back in the classroom. Sound harsh? That's been school policy for years for the measles, mumps, and other vaccines.

All public sector employees, federal, state, and local, should be ordered to get the vaccine including all military personnel.

Finally, health insurance companies should be allowed to charge higher premiums for those who refuse the vaccine without a legitimate medical reason. We should make an exception for a once in a 100 years pandemic.

It is highly inconsistent to support mandating masks and social distancing laws without also mandating vaccines for those without a legitimate medical reason or are under the age of 12.

France's Covid-19 vaccine rollout hits 20 million target

Macron announced the milestone in a tweet that said "20 million" with a green checkmark, a number that represents around 30 percent of the population. Health officials said the exact figure was 20,086,792; with 8,805,345 people having also had a second vaccine dose. "Again nearly 600,000 vaccinations today," Health Minister Olivier Véran tweeted late Friday. "Tomorrow, 20 million French will have had at least one dose," which would represent nearly 30 percent of the population.

Authorities also reported further declines in the number of patients requiring intensive care in hospitals. The number of people in intensive care stood at 4,352 on Friday, a decline of 90 from the previous day and well below the peak of 6,001 during the "third wave" of infections that battered France starting in March.


Mask mandates, social distancing, and limited capacity are not just "minor inconveniences".

COVID-19 mitigation measures were exactly the correct policy prescription in the early days of the pandemic when there was no vaccine or other cures, and the surge in hospitalizations threatened to overwhelm our entire health care system. I am not arguing that the mitigation measures were not needed. However, it's equally wrong to say that mask mandates, social distancing, and limited capacity rules are just "minor inconveniences". They may be to you, but not to everyone.

There are several jobs and businesses that rely on human interaction in order to survive. Think restaurants, bars, movie theaters, tourism, hospitality, gyms, hair salons, barber shops, public transportation systems, etc. COVID-19 mandated mitigation measures can decimate how these businesses function as customers won't patronize them if they're forced to wear masks and social distance. To some, these measures are an inconvenience. To others, their business may be forced to close.

My position is simple. If the science and the data require mandated mitigation measures, we should follow the guidance and support these businesses and their employees. If the science and the data say that the vaccines eliminate the need for these mitigation measures, we should move forward without them.

Calling these mitigation measures a "minor inconveniences" is being tone deaf to the needs of others.

The CDC does not issue mask mandates. State governments do.

The CDC issues guidelines that the states can follow or not. There is no central authority mandating anything. TX and FLA removed all mask mandates and other restrictions back in early March, and we have not seen spikes in hospitalizations or deaths from their decisions. In fact, it's been just the opposite. We've seen 70% and 80% declines over the last 5 months in hospitalizations and deaths from their peak in January of this year.

The CDC's guidelines reflect the data that they're seeing here in the U.S. and in Israel. The vaccinated have a very low risk for getting a severe case of COVID-19 and they do not carry enough of a viral load to spread the disease.

The risk is now shifted from the state to mitigate to the individual. Everyone will have different challenges and need to consult their doctor, but for now, the vaccinated have sufficient enough protection and no longer need to wear masks.

Trends in Number of COVID-19 Deaths

Peak 7-day moving average in the new number of new deaths from COVID (1/13/2021): 3,422
Current 7-day moving average in the new number of new deaths from COVID (5/13/2021): 599
Percentage change: -82.5%

Peak new deaths from COVID (1/13/2021): 4,195
Current new deaths from COVID (5/13/2021): 733
Percentage change: -82.5%


CDC COVID New Hospitalizations Tracker

Current 7-day Average (5/6/2021 to 5/12/2021): 3,956.3
Prior 7-day Average (4/29/2021 to 5/5/2021): 4,556.0
Percent Change: -13.2%

Peak 7-day Average (1/3/2021 to 1/9/2021): 16,578
Percent change from Peak to Current: -76.1%


Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections

Following the emergency use authorisation of the Pfizer–BioNTech mRNA COVID-19 vaccine BNT162b2 (international non-proprietary name tozinameran) in Israel, the Ministry of Health (MoH) launched a campaign to immunise the 6·5 million residents of Israel aged 16 years and older.

Two doses of BNT162b2 are highly effective across all age groups (≥16 years, including older adults aged ≥85 years) in preventing symptomatic and asymptomatic SARS-CoV-2 infections and COVID-19-related hospitalisations, severe disease, and death, including those caused by the B.1.1.7 SARS-CoV-2 variant.

The Lancet:

At some point soon, free hospital treatment of COVID-19 for the unvaccinated should end.

If you forgo the vaccination and contract a severe case requiring hospitalization, then you should have to pay for your treatment just like a smoker pays for treatment from illnesses resulting from smoking cigarettes.

If you have been vaccinated and contract a severe case requiring hospitalization, then you should not have to pay for treatment, or the government should reimburse you or your insurance company.

Getting vaccinated should be a requirement by your health insurance company or you don't get coverage.
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