The following is reported, but redacted and altered; from a major news source today. July 14, 2020:

Covid-19 vaccine developed by the biotechnology company M****** in partnership with the National Institutes of Health has been found to induce immune responses in all of the volunteers who received it in a Phase 1 study. These early results, published in the New England Journal of Medicine on Tuesday, showed that the vaccine worked to trigger an immune response with mild side effects -- fatigue, chills, headache, muscle pain, pain at the injection site -- becoming the first US vaccine candidate to publish results in a peer-reviewed medical journal. The vaccine is expected to begin later this month a large Phase 3 trial -- the final trial stage before regulators consider whether to make the vaccine available. Early results from M****** coronavirus vaccine trial show participants developed antibodies against the virus M****** noted in a press release on Tuesday that, if all goes well in future studies, "the Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021." In the Phase 1 study, "the goal was to look at safety and then to look at immune responses," said Dr. Lisa Jackson, a senior investigator at Kaiser Permanente Washington Health Research Institute in Seattle who was involved in the study. Early data from the study previously was released in May. "We thought the immune responses look promising, but we don't know whether the levels we're seeing would actually protect against infection. It's really hard to know that until you do the actual efficacy trial," she said. "So we're laying the groundwork for the trial that will provide those answers." Coronavirus vaccines: 'Encouraging' early data for some, a trial delay for another and more research ahead M****** expects to start the company's largest study yet of its Covid-19 vaccine candidate mRNA-1237 on July 27, according to details released separately on Tuesday. It's expected to be the first in the United States to begin Phase 3 trials. For now, the new study "provided information rapidly that could be used to determine what dose to go forward with Phase 2 and Phase 3 trials. That's a critically important decision to make and so having that information available so soon after the vaccine trial was initiated is pretty remarkable," Jackson said. A Phase 1 study typically studies a small number of people and focuses on whether a vaccine is safe and elicits an immune response. In Phase 2, the clinical study is expanded and the vaccine is given to people who have characteristics -- such as age and physical health -- similar to those for whom the new vaccine is intended, according to the US Centers for Disease Control and Prevention. In Phase 3, the vaccine is given to thousands of people and tested for efficacy and again for safety. 'We want to know whether the vaccine is safe and effective. 'The Phase 1 study included 45 healthy adults, ages 18 to 55, who received two vaccinations of the mRNA-1237 vaccine candidate 28 days apart. Some of the volunteers enrolled in the trial at Kaiser Permanente in Seattle and others at Emory University in Atlanta. The volunteers were separated into groups where they either received the vaccine at a dose of 25, 100 or 250 micrograms. They received their first vaccination between March 16 and April 14. Here's where we stand on getting a coronavirus vaccine. "The first dose sort of sets the immune system up, it's called priming," Jackson said. "So that when you then administer the same thing again, there's a booster response. There's an augmented response. So we did not think that one vaccination would be sufficient to get the level of response that we wanted to see. "The researchers found "no trial-limiting safety concerns" after volunteers received their two doses of vaccine, but there were some mild to moderate side effects, such as some pain at the injection site, and there were more of those the higher the dose of the vaccine. After the first vaccination, adverse events were reported by five participants in the 25-microgram group, 10 in the 100-microgram group, and eight in the 250-microgram group. Then after the second vaccination, such events occurred in seven of 13 participants in the 25-microgram group, all 15 in the 100-microgram group, and all 14 in the 250-microgram group, with three of those participants reporting "one or more severe events," according to the study. The most commonly reported systemic adverse events following second vaccination at the 100-microgram dose were fatigue, among 80%; chills, among 80%; headache, among 60%; and myalgia or muscle pain, among 53%; all of which were transient and mild or moderate in severity, as noted in M******s press release. A coronavirus vaccine is still months away, but an antibody treatment could be closer. The study data also showed that the vaccine induced an antibody response. Antibodies are the proteins the body makes to fight infection. Specifically, all participants developed neutralizing antibodies to the virus at levels similar to those seen in people who've naturally recovered from Covid-19, according to the study. Neutralizing antibodies bind to the virus, disabling it from attacking human cells. The researchers measured two types of immune responses, Jackson said." Those two types of responses support each other. We know that the antibodies are being produced and it appears that there's function after vaccination that serves to block the ability of the virus to enter cells. So it neutralizes the activity of the virus," she said. Why expert is cautious about Covid-19 vaccine trial results? But more research is needed. "What do we really want to know? We want to know whether the vaccine is safe and effective, that's what we want to know," said Dr. Paul Offit, a member of the NIH panel that's setting a framework for vaccine studies in the United States, who was not involved in the new study. With the study, "we know that it's safe in 45 people, which is not going to be the 20 million people or 200 million people who are going to get it here in the United States," said Offit, who is also director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children's Hospital of Philadelphia. "So we know that it doesn't have a very common side effect problem, that's what we know," he said. "Then we don't know anything about efficacy, which is what we really want to know. Is this vaccine going to work? The only way to know that is to do a so-called Phase 3 trial. "M****** expects to start large US Covid-19 vaccine trial in late July. Results from the Phase 1 study can help guide what the Phase 3 study looks like. "These Phase 1 data demonstrate that vaccination with mRNA-1273 elicits a robust immune response across all dose levels and clearly support the choice of 100 μg in a prime and boost regimen as the optimal dose for the Phase 3 study," Dr. Tal Zaks, chief medical officer of M******, said in the company's press release on Tuesday. "We look forward to beginning our Phase 3 study of mRNA-1273 to demonstrate our vaccine's ability to significantly reduce the risk of COVID-19 disease," he said. M******'s coronavirus vaccine announcement set off a frenzy on Wall Street. Now some are calling for an investigation. For the Phase 3 study, researchers plan to enroll 30,000 adult participants, including people whose locations or circumstances put them at high-risk of infection. One group will be injected with 100 micrograms of the vaccine on day 1 and again on day 29. A second group will be injected with two doses of a placebo for comparison. Fourteen days after the participants get their second dose, the researchers will be looking at whether they develop Covid-19. The participants will be followed for two years after receiving their second dose. The study will be conducted at 87 locations across the United States. M*******'s vaccine candidate is one of 23 in clinical trials around the world, according to the World Health Organization. Overall, "the safety and immunogenicity data in this preliminary report are promising, and they support continued development of this vaccine. However, we must bear in mind the complexity of vaccine development and the work still to be done before Covid-19 vaccines are widely available," Dr. Penny Heaton, chief executive officer of the Bill and Melinda Gates Foundation, wrote in an editorial accompanying the Phase 1 study in the New England Journal of Medicine on Tuesday. "Accelerating the development of Covid-19 vaccine candidates beyond phase 1 depends on continued parallel tracking of activities and fulsome resources. The world has now witnessed the compression of 6 years of work into 6 months," Heaton wrote. "Can the vaccine multiverse do it again, leading to a reality of a safe, efficacious Covid-19 vaccine for the most vulnerable in the next 6?"

I see nothing about subjects so ill that they dropped out, this should be reported as it alters the data, conclusions, etc.

So, it is going to take a long time.

Good luck, stay safe, and thank you. Pray for them, and us

I really don't want to say the words "ins**** tra****" but after hearing numerous comments from colleagues, I had to?!!

sorry, but it is upsetting.

It is a good thing that so many labs are working on this problem. I assume the timetable on these 400,000,000 doses is late 2021. The US market should produce 500,000,000 to a billion doses. The other question is are two shots needed, then the number of doses needed obviously doubles. Plus, there are 7 billion other people who will also need a vaccine. But then again there are over a hundred other labs working on this, so with hope it can be done and the world immunized by 2022. That does seem like a long time to wait, doesn't it. With no "cure" yet as well, its strict social hygiene until then.

Literally hundreds of labs are working on this problem, probably one of the largest scientific endeavors ever undertaken. I have heard that your country has Phase 3 trials in effect. The USA published in NEJM yesterday completing Phase 2 successfully and going into Phase 3 now with 30,000 test subjects soon. Many other countries are in various stages of development. In

Canada we have several trials going on as well. The NEJM stated that they should have in the USA, 500,000,000 to 1 billion doses of vaccine ready to give in 2021. Yes, it is slow, but they are trying to get it right. Also, Dr. Fauci says with the hundred or so companies trying to produce a vaccine there will be many different good ones to go around, basically, and I am paraphrasing him, thank you. July 15, 2020.

This article brings up some appropriate concerns regarding one of the major vaccines being developed. Apparently in monkeys immunity lasted 3 months at best?:

Said with caution. The infection itself seems to only provide short-lived immunity, if at all. We do not have the vaccine experience for over a few months yet. It may be short-lived as well. Time will tell. In the meantime, work with other methods of vaccination should be ongoing. A more robust T-cell response may be desirable for long-term immunity. Maybe even the one based upon the carrier pseudorabies. Note that Pasteur's initial rabies vaccine which he derived from phenol attenuated live rabies virus still works well after almost 200 years! Hundreds of vaccine choices hopefully will be available and we can choose the best one, or several? Be safe, thank you again. July 30, 2020; Gary Ordog, MD

August 29, 2020 Update: Finally taking my advice to expedite administration, they may "fast-track" the vaccine. But, of not, this will probably mess up the desired research studies, placebo controlled double blinded randomized experiments that are most desirable. This is also going to decrease transparency into that true experimentation. Well the masses will be vaccinated, adverse results will be published in the news, and the plaintiff attorneys may have their field-day!? (No word yet if heavy metals are being used? I hope, at least, they avoided this fiasco)

August 29, 2020.

Dr. Brix says it will be safe.

NIH today n headline News:

A major concern published in JAMA today. Apparently, the vaccines for COVID-19 will not stop the worrying. Here is part of the story:

Can Vaccinated People Stop Worrying About COVID-19?

While a vaccine will help protect individual patients and those around them, a large proportion of the population must be immunized and protected before transmission is substantially reduced. Especially for 2-dose regimens, this will take months. No vaccine will be 100% effective and a vaccine that protects against developing clinical illness may not prevent transmission to others. Also, the duration of naturally occurring immunity to infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is unknown and may wane with time.9 Therefore, the likely duration of protection by new COVID-19 vaccines is unknown.

For these reasons, even after vaccines become available, SARS-CoV-2 will be a continuing concern. Effective public health measures, such as social distancing, limiting the size of gatherings, and wearing masks, will be needed for at least several more months, and potentially longer.

Conclusions

Many individuals are hesitant about receiving COVID-19 vaccines. Reasons include the novelty and rapid development of the vaccines, as well as the politicization of the pandemic and inconsistent messages from scientists and government leaders. It is critical that clinicians stay well informed about emerging data so that they can help patients make sound decisions about the vaccines needed to help end the pandemic.

Article Information

Corresponding Author: Jesse L. Goodman, MD, MPH, Medicine and Infectious Disease, Georgetown University School of Medicine, 3900 Reservoir Rd, Washington, DC 20057 ([email protected]).

Published Online: October 16, 2020. doi:10.1001/jama.2020.20590

So, apparently life will continue on like this even after we are given the vaccines. We were all hoping to get back to normal. Looks like masks, gloves, sanitizer, social distancing are in effect permanently. I say once again, please stay safe, and thank you for your support, October 16, 2020; Gary Ordog, MD.

The Cutter incident: A cautionary tale for Operation Warp Speed

The following article is appropriate at this time, with evidence that the process must be totally transparent, the data must be analyzed by all, and the conclusions should be followed. The Cutter Incident demonstrates what can happen in vaccine development, if data is ignored, covered up, negative results are eliminated from the final report.

"By Paul Danish - July 23, 2020: Wellcome Library, London

The Trump administration is calling its push for a coronavirus vaccine “Operation Warp Speed.” If you don’t find the name cringe-worthy, you’re not old enough to remember the Cutter incident. 

I am.

Back in the 1950s, the disease that terrified the country was polio, aka poliomyelitis, aka infantile paralysis. The disease could kill you, but its real terror lay in its ability to leave its victims paralyzed, often permanently. While it frequently struck children (thus the name infantile paralysis) its most famous victim was President Franklin Roosevelt, who even after years of therapy could barely walk.

So when it was announced in April 1955 that a polio vaccine developed by Dr. Jonas Salk had been proved effective in tests on two million school children, the country was overjoyed — and the government did everything it could to have the Salk vaccine produced at, uh, warp speed.

It did this by giving several pharmaceutical companies licenses to make the vaccine, one of which went to Cutter Laboratories, of Berkeley, California. The company, which had been founded in 1897 by Edward Ahern Cutter, was not a fly-by-night operation. Its products had included an anthrax vaccine and hog cholera vaccine. During World War II, it produced penicillin.

The Salk polio vaccine was a dead virus vaccine. It has since been displaced by the Sabin vaccine, which uses attenuated live virus and can be given orally. But in the spring of 1955, the Salk vaccine was the best medicine had to offer.

So companies like Cutter Labs were producing and shipping it as fast as they could. Here’s how Wikipedia succinctly describes what happened. Although I was not yet 13 at the time, the description squares with my memories.

Some 120,000 doses of Cutter’s vaccine contained live, unattenuated polio virus.

Of the children who received the vaccine, 40,000 developed abortive poliomyelitis (a form of the disease that doesn’t involve the central nervous system), 56 developed paralytic poliomyelitis, and of these five died. A further 113 people contracted paralytic polio from the inoculated kids. Five of them died too.

Heads rolled in the federal government. Oveta Culp Hobby, secretary of Health, Education and Welfare (today the Health and Human Services Department) resigned. So did Dr. William H. Sebrell Jr., the director of the National Institute of Health (NIH).

A Congressional inquiry in June 1955, two months after the incident concluded that Cutter’s production methods were sound, but that the NIH’s Laboratory of Biologics Control hadn’t exercised proper scrutiny and oversight. The lab had received advanced warnings of problems, and one staff physician, Dr. Bernice Eddy had reported to her superiors that some inoculated monkeys had become paralyzed. She even sent them pictures. Sebrell swept the warnings aside.

Lawsuits ensued, of course. A jury found Cutter not negligent, but liable for breach of implied warranty, and awarded damages. Subsequent cases brought against Cutter and three other companies that had problems completely inactivating the virus were settled out of court.

The lesson here for Operation Warp Speed is that a rush to get a vaccine out the door can have fatal consequences. And in the case of the coronavirus vaccines under development, the risks are inherently larger than with Cutter’s Salk vaccine. That’s because the coronavirus vaccines are going to be shipped without a couple of years worth of human testing. A protracted testing period doesn’t just provide information about the safety and effectiveness of a vaccine. It also provides the vaccine producers and government regulators with time to develop robust product safety procedures. Can that be done at warp speed? Maybe, but warp speed seems to be an open invitation to a new Cutter Labs incident. 

The feds should forget about warp speed and avoid cutting corners, especially when it comes to vaccine production.

And especially since there is some evidence that an existing vaccine, the Sabin oral polio vaccine, may be effective against coronavirus. Dr. Robert Gallo, co-discoverer of the HIV virus as the cause of AIDS, recently authored an op-ed in the Wall Street Journal stating he and a colleague believed the Sabin vaccine is “known to be a potent stimulus of the innate immune system” and that an innate-immunity vaccine like Sabin “can provide nonspecific protection against a range of viruses and become effective in hours, not weeks.”

“We propose OPV (Oral Polio Vaccine) because of its availability, simplicity (a tablet), very low cost and decades long safety record… Billions of people have received OPV, including nearly everyone in the U.S. between 1962 and 2000,” he wrote.

“Stimulating the innate immune system with OPV looks like a free and safe option for saving lives while we wait for an effective COVID-19 vaccine,” he concluded."

Perhaps, complete transparency of the results of the Cutter vaccine testing, may have prevented this disaster, we will never know. The paralysis of the vaccinated monkeys, was somehow ignored (at best). I do note for investors and corporate executives, that this "incident" led to the closure of the company with obvious huge losses to all. Vaccination is essential for continued normal human society, but again, the risk-benefit ratios must be discussed completely and openly. I wasn't there at the time, but some must have thought the risk was worth it.