Pfizer Covid Pill Seeks FDA Approval


Soon you may be able to treat Covid-19 as easily as you would a urinary tract infection. Pfizer pharmaceutical has asked the FDA to authorize their easy-to-use pill for home treatment in high-risk patients.

Other options for Covid treatment have mostly required hospitalization. Gilead Sciences, Inc. produced the antiviral drug remdesivir, but it requires parenteral treatment which means hospitalization. Monoclonal antibodies have proven effective but are costly and typically given in doctors’ offices or hospitals.

Jared S. Hopkins, writing in The Wall Street Journal, says clearance from the FDA would give patients and doctors an easy-to-use treatment to keep people out of the hospital early in the course of the disease. “There is an urgent need for lifesaving treatment options,” Pfizer Chief Executive Albert Bouria said. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients.”

The Pfizer drug is called paxlovid. President Biden has said the U.S. has secured supply of the Pfizer drug. A person familiar with the matter said the U.S. was working on a contract for 10 million courses of treatment. Pfizer projects it will manufacture more than 180,000 courses of treatment this year, and plans to increase production to at least 50 million courses next year.

Paxlovid reduced the risk of hospitalization or death in high-risk people in a late-stage study with mild to moderate Covid-19 by about 89% if they took the pill within three days of diagnosis, according to Pfizer. Researchers reported paxlovid was found to be generally safe and well-tolerated. Paxlovid was performing so well in the trial that Pfizer said it stopped enrolling subjects after discussions with the FDA. Drug makers typically stop studies, after discussion with health regulators, if an experimental drug is found to be so effective that it would be unethical to continue the study including subjects who received a placebo.

If approved, the drug could be taken at home shortly after they first develop Covid-19 symptoms. A course of treatment consists of 30 ills over five days. Twice a day, patients would take two pills of paxlovid and one pill of another antiviral called ritonavir.

This comes on the heels of earlier reports that Merck and Ridgeback Biotherapeutics have produced their own Covid pill call molnupiravir. (see Covid Pill Should be Coming Soon) With these companies applying for FDA approval of outpatient oral treatments for Covid, the future looks much brighter. Merck is still waiting for FDA approval, however. Merck has also licensed out production of molnupiravir to generic drugmakers in India.

Paxlovid works differently from the Merck-Ridgeback pill and presents fewer safety concerns, according to some physicians and scientists. Researchers designed the Pfizer pill to stop the coronavirus from spreading in people by blocking activity of a key enzyme, known as protease, that the virus needs to replicate. Drugs blocking protease have proven effective in treatment of other viruses, like HIV, which causes AIDS.

The FDA has shown reluctance to approve the Merck-Ridgeback pill without Phase 3 trials.  It remains to be seen if this will be an impediment to approval of the Pfizer pill.

Opposing Vaccine Mandates


America is learning to live with Covid. The Biden Administration and many corporations are pushing vaccine mandates, but America is pushing back.

Many government mandates have already been rescinded because too many firefighters and police officers were going to be terminated for refusing to be vaccinated. Many corporations have also walked back their mandates when they realized they wouldn’t have enough workers to keep the doors open. It’s great to be confident your workers won’t get sick, but you’ve still got to be able to provide the services the public needs. Missing from these mandates was scientific and common sense. If you’ve already had Covid, you’ve got natural immunity and you don’t need the vaccines. If you create a working environment where no one wants to work, you can’t keep your workers.

Once again, Florida Governor Ron DeSantis is taking the lead in pushing back against government and corporate mandates. Earlier, DeSantis took action to prevent cruise ships in Florida from mandating vaccinations for all passengers. That decision is currently being challenged in the courts. This week he signed a quartet of bills that put new restrictions on vaccine mandates by employers. “We’re making sure that people have a right to earn a living,” DeSantis said. “We are respecting people’s individual freedom in this state.”

The bill was the product of a special legislative session called by the governor. The main bill, HB1B, bans vaccine mandates by local governments on employees. For private businesses, any vaccine requirements for workers must include exemptions for religious or medical reasons. Any worker who previously had Covid-19 is also exempt, as well as anyone who agrees to regular testing for Covid-19 and wearing protective gear.

The bill is a direct response to President Biden’s executive order imposing a vaccine requirement on businesses with more than 100 workers.(The Fifth U.S. Circuit Court of Appeals has since stayed the mandate’s enforcement.)

To be sure, DeSantis did not get everything he wanted in the bill. The new law expires in June 2023 and doesn’t help workers who were already subject to vaccine requirements by private businesses. Walt Disney World, the largest employer in Central Florida, required its workers to be inoculated earlier this year after negotiating with its unions. DeSantis has already filed suit against the Biden rule but wanted to go further with new state laws restricting vaccine mandates. The rule has already been temporarily stayed by a federal court in a separate case, and DeSantis has stated he believes it will be struck down.

The latest statistics show 196 million Americans or 71% of adults are fully vaccinated; 228 million or 82% are partly vaccinated. If you add in those who have survived a Covid infection and have natural immunity, the number of unvaccinated people without natural immunity is quite small. These “antivaxxers”, as they have become known, are unlikely to change their minds in the near future.

Robert F. Kennedy, Jr. appears to be the darling of the antivaxxers. He recently released a book, called The Real Anthony Fauci, in which he accuses Dr. Fauci, Bill Gates, and Big Pharma of being partners in a $60 billion global vaccine scheme that flooded the world with propaganda exaggerating Covid’s dangers. It has become an instant Amazon bestseller. I’m no fan of Fauci or Gates, but I doubt Gates needs the money. And Big Pharma has its many detractors, but where would the world be now if not for the vaccines they have produced? We should not be surprised that Kennedy is an antivaxxer about Covid. He is the same Kennedy responsible for spreading lies about vaccines causing autism. We should also realize that being against vaccines is not a conservative ideology. Kennedy is a hard-left liberal.

With most of America vaccinated or having acquired natural immunity, it’s time to let people make up their own minds. I am definitely pro-vaccine – I’ve had three Pfizer shots and my wife has had 3 Moderna shots. I believe the government should encourage people to get vaccinated, but vaccine mandates violate our freedom to choose what’s best for us. Those who choose to refuse vaccination understand the risks – now let them make their own decisions.

(Disney suspended their vaccine mandate shortly after Governor DeSantis signed the bill.)

The Control Pandemic


Since early 2020, the world has been experiencing a pandemic due to the novel coronavirus we now call SARS-CoV-2 or Covid-19. This has claimed the lives of 767,433 Americans and 5,126,415 people worldwide according to the Johns Hopkins Corona Virus Resource Center.

Naturally, this has brought changes to our world we have all become accustomed to living with, including wearing masks, social distancing, and frequent use of hand sanitizers. Most Americans have received vaccinations from a variety of vaccines including those produced by Pfizer, Moderna, and Johnson & Johnson. In other countries many other vaccines are being used with varying effectiveness.

I’ve just returned from a trip to Europe where I experienced the full impact of the changes Covid has brought to our world in a very personal way. In preparation for my trip, I had to prepare documentation far beyond the usual federal passport and travel documents. It was necessary to also produce documentation of vaccination more than two weeks before departure. I had to have a PCR Covid test performed less than 72 hours before departure with a written report of a negative test.

Since my trip was predominately to France, I needed a French Health Pass, which had to be obtained from a French government website where most of the information was only in French. I also needed a Certificate of International Travel, also only available from a French government website. Getting all this information in written documents took me most of a day and challenged me to the full extent of my computer expertise.

Finally prepared, I began my travel at the Orlando airport where the agent at check-in required my passport, proof of vaccination, and a negative Covid test. She was uninterested in my French Health Pass or Certificate of International Travel. She lamented that she had been turned into an immigration agent, not just an airline counter agent. Upon arrival in France, no one checked my documents until I embarked upon my river cruise ship.

The river cruise ship checked my passport, vaccination passport, and the results of the Covid test. They too were uninterested in the French Health Pass or Certificate of International Travel. However, they did declare my negative Covid test invalid since it was obtained 80 hours before arrival on their ship. They promptly tested me again and, thankfully, found me still negative!

Over the next 16 days I was tested daily for Covid with a saliva test each morning. Counting the test performed before departure and the one upon arrival, that makes 18 Covid tests in 20 days! All were negative. The experience of my co-travelers on the ship was similar. We were all tested daily, all fully vaccinated, and yet all required to wear masks in the presence of others, including excursions whether on buses or by foot, indoors or outdoors. To be sure, many of us were non-compliant at times when we thought we could get away with it!

Upon my return flight preparation, I was informed I would need a Netherlands Transit Form filled out since my flight plans passed through Amsterdam. I dutifully downloaded this form from the Netherlands’ website, then had to get help printing the form since the onboard computer had no printer. The form required my signature. When I got to the airport, the French counter agent wasn’t really interested in that form, but said they would check it in Amsterdam. But he informed me I would also need a similar form for reentry into the United States. As it turned out, no one in Amsterdam or the U.S. ever asked for these forms.

Those who have chosen to avoid vaccination for Covid are seeing their world shrink rapidly. It is currently impossible to fly internationally without proof of vaccination. It is also unlikely you will be able to take a cruise anytime in the near future. Failure to wear masks on airplanes is being treated as a federal offense, literally, and I wouldn’t be surprised if even domestic airlines insist on vaccination soon. In truth, airplanes represent one of the safest ways to travel, not only for their excellent safety records, but also because their air filtration systems rival the best operating room suites. Wearing masks on airplanes makes no sense at all, especially if you have been vaccinated.

All this lacks scientific credibility. It is more about control. The Covid pandemic has given those who seek control a golden opportunity to restrict our freedoms. This is mostly seen in local, state, and federal governments, in this country and world-wide. It is also being seen increasingly in private corporations, mostly out of concerns about diminishing profits and liability issues. But one has to wonder if these corporations are actually sacrificing profits in the name of virtue signaling, government cooperation, or heightened liability concerns. Our river cruise ship was only two-thirds full when the usual situation is packed cruises well in advance. Government officials may also suffer the consequences of these restrictions of our freedom in the next election.

Fear makes people compliant. We saw this dramatically after the 9/11 terrorist attacks. People were mostly willing to give up some privacy in the name of tracking down terrorists so the Bush administration easily justified the Patriot Act. Today we are seeing this in response to the Covid pandemic. Many fearful people willingly submit to even unscientific government policies such as wearing face masks even outdoors in vaccinated people!

Fear generally makes people do things, or accept things, they normally would not tolerate. We must all consider this in the coming days as wearing masks becomes an acceptable norm in society world-wide. But fear is not of God. The Bible offers comfort, whether you favor the Old Testament or the New Testament:

Isaiah 41:10“Do not fear, for I am with you; do not anxiously look about you, for I am your God. I will strengthen you, surely I will help you, surely I will uphold you with My righteous right hand.”

II Timothy 1:7 – “God has not given us a spirit of fear, but of power and love and discipline.”