The data from Pfizer’s 40,000+ volunteer phase 3 clinical trial begun a year ago and reported to the FDA in December showed a 95% efficacy to prevent severe infection, including hospitalization and death. The vaccine was equally effective at all ages. The results, published in the New England Journal of Medicine, were beyond even the most optimistic hopes when the trial began.

A home run for sure and, with an excellent safety record, more than enough for the FDA to grant emergency use authorization in mid-December 2020. The results were similar for the Moderna vaccine, which was authorized just a few weeks later. The Johnson & Johnson vaccine was authorized in February 2021.

When the Pfizer data was submitted, the longest any volunteer had been vaccinated was a few months. In April 2021, Pfizer reported that antibody levels had declined among the volunteers, and efficacy then stood at about 91%, still excellent.

Antibody levels, especially neutralizing antibody concentrations in the blood, appear to be critical to vaccine efficacy. The half-life of neutralizing antibody is about two months. Therefore, that model predicts that after about 250 days after vaccination, the antibody level will be significantly less able to prevent infection but still sufficient to prevent severe illness and death.

Older people have shown good protection so far, despite their initial lower antibody levels after vaccination(see image above) compared to younger individuals. Among the unvaccinated, older individuals who develop Covid-19 are at much greater risk of an adverse outcome than a younger person. Since antibody levels decline over time, older vaccinated individuals starting with a lower antibody level might be expected to be at higher risk sooner.

Breakthrough infections among vaccinated people are relatively rare, but they seem to be increasing in frequency. An exposed person may develop an infection, and it will probably be asymptomatic or “relatively mild.” But even so-called mild infections can cause loss of work, fatigue, cough that lasts for a few days to a few weeks. Some symptoms have been reported to last at least six weeks, perhaps longer. For an older person, especially those with multiple chronic conditions, even a “mild” infection can be debilitating. And some do proceed to hospitalization and death.

What has become strikingly clear in recent days and weeks is that the vaccinated can readily become infected, especially to the Delta variant, when exposed to an infected person, whether that person has been vaccinated or not. For example, multiple events were held during the July 4th weekend and beyond in and near Provincetown, Cape Cod (Barnstable, County.)

Within some days, 469 Covid-19 infections were identified (image above)among people who had traveled to that area between July 3 and 17, 2021. 74% were fully vaccinated. The Delta variant caused approximately 90% of these infections. Both vaccinated and unvaccinated had similar virus concentrations in their nose samples. Five patients were hospitalized; to date, there have been no deaths.

Dr. Allan Massie, a Johns Hopkins Covid-19 epidemiologist, went to a party in Maryland with 14 friends. All were fully vaccinated, so they wore no masks, consistent with CDC guidelines. Within a few days, 11 developed Covid-19. He published his experience, noting that he had fever, chills, muscle aches, and been weak enough that “I can hardly get out of bed. I don’t wish this on anybody.”

The Israeli government, in collaboration with Pfizer, conducted one of the most effective vaccination campaigns of any country beginning in January 2021. Within a few months, 80+% of the eligible population was vaccinated.

In late July, a study at Hebrew University reported that vaccine efficacy to prevent serious infections had dropped to 80%, still good but not as good as before. Most infections were due to the Delta variant. And a short time later, another study indicated that those who were vaccinated first (e.g., January and February) were more likely to develop a breakthrough infection, usually with the Delta variant, compared to those vaccinated later in the spring. To be fair, it is possible that those vaccinated early had more underlying diseases that predispose to serious covid-19 infections, creating a bias.

Nevertheless, this information was sufficient for the Israeli government to offer, as of July 29th, a booster dose to those over 60 who were vaccinated five or more months before.

Will this make a difference in preventing severe infections? Logic says “Yes,” and Pfizer plans to request authorization for a booster shot in the United States during August. Moderna will follow suit, as will Johnson & Johnson.

When the CEO of Pfizer announced a few weeks ago that he believed boosters would be necessary, much of the media was cynical, noting that Pfizer is a for profit company and just wanted to sell more doses. This was an often “reflex” reaction against capitalism. It is unfortunate because it was Pfizer, like the other vaccine developers, that committed huge sums to rapidly develop these incredible vaccines.

Germany, France, and Britain plan to offer booster shots for older and immune-compromised individuals beginning shortly. The US government is considering them but has not reached a decision, at least not publicly. However, news reports on August 9th suggested that a decision to offer boosters to the immunocompromised was “imminent.” The US has purchased an additional 200 million doses from Pfizer to be allocated to children under 12 years old, if authorized, and for potential boosters.

Government officials remind us that the vaccines are still generally effective in preventing hospitalization and death. That is undoubtedly true but not sufficiently soothing if a booster would help both prevent infection and its “mild” symptoms and, importantly, concurrently reduce transmission. As the Hopkins epidemiologist noted, even mild infections can be debilitating. And as other reports documented, some people with breakthrough infections can have persistent symptoms for more than six weeks.

These multi-person breakthrough infections among the vaccinated are concerning. They seem to be a relatively new occurrence. Indoor masking by all, regardless of vaccine status, will help. Getting more Americans vaccinated will help. And providing boosters, at least to the more vulnerable vaccinated, will help. Until the spread of the virus is curtailed, everyone is at risk. It is time for boosters to begin. The US has or will have plenty of available doses for all who desire them.

Of course, there is the legitimate issue of vaccine equity. Billions of people around the globe have not been vaccinated. They need to be, not only for their own sake but to help prevent the development of another more lethal variant. America has purchased 500 million doses of the Pfizer-BioNTech vaccine and placed orders for other companies’ vaccines for worldwide distribution.

Other developed countries have likewise purchased vaccines for widespread distribution. More purchases will be needed. Until we are “all safe, no one is safe.” The World Health Organization director has implored developed country governments to forgo boosters in favor of sending more vaccines abroad. So far, government responses have been to both offer boosters and ship doses concurrently.

I think these are two separate issues. The relatively few shots used for boosters would not make a sizeable dent in the world’s supply. But it will help Americans stay safe, reduce transmission and limit the opportunity for another variant to develop right here at home.

Said differently, worldwide vaccination is not a zero-sum game. Let’s not penalize those who did the right thing and got vaccinated as soon as it was available here in the United States. Meanwhile, it is also in our best interests to purchase and distribute as many vaccine doses as can be manufactured over the coming years and distribute them to countries in need. It will be money well spent.

Yes, I am biased, but boosters make sense and the time to start is now.

The post The Time for a Vaccine Booster is Now appeared first on Medika Life.

We would go to the store and buy a piece of chuck, come back and cut it up and the guys would put it through Grandma‘s old meat grinder. They make nice thick patties and slice up some summer squash and cook them either outside on a charcoal grill or inside over the wood coals in the fireplace. Just add some vine ripe tomatoes.

Now that’s a real burger.

But now, two companies, with more rapidly following, have developed a plant-based “beef” product that looks, tastes, smells, and feels like the real thing.

The two companies are Impossible Foods and Beyond Meat.

Impossible Foods uses organic genetically modified soy protein as the base substance. The soy contains leghemoglobin which a special yeast can convert to heme giving the red color to the “beef.”

The burger has 21 ingredients including also potato protein, coconut oil, sunflower oil, yeast extract, dextrose, food starch, methylcellulose and various flavorings. Initially containing wheat products, the current formulation does not.

One concern raised (in the Livestock News) is that the high concentration of soy product can have an estrogen-like effect but that is highly unlikely and the FDA has certified it as generally recognized as safe.

Beyond Meat bases its burger on a non-organic, non-GMO yellow pea protein isolate. Among other ingredients is expeller pressed canola oil, rice protein, refined coconut oil, cellulose from bamboo, methylcellulose, potato starch, maltodextrin, yeast extract, salt, sunflower oil, vegetable glycerin, gum Arabic, and citrus extract plus natural flavors.

The red color of beef is created by beet juice. A quote from Ethan Brown, the company’s founder, “[Meat] is essentially these five things. It’s amino acids, lipids, trace minerals, trace vitamins, and water…None of those are exclusive to the animal. They’re all present in the plant kingdom.”

Overall, both products are essentially processed foods with a very high number of ingredients albeit all from plants.

Beyond Meat was founded by Ethan Brown in 2009. He has a degree from the University of Maryland where his father is a former professor in the Agriculture School. Brown grew up, in part, on a farm. As to the process, the company has found a method of heating, cooling, pressing, and mixing plant products into what look and taste like burgers and other meats.

“What we’re doing, I don’t think about it as meat substitutes or meat alternatives,” Brown said in an interview. “We’re actually building a piece of meat directly from plants.”

Patrick Brown, no relative of Ethan, founded Impossible Foods. He is a biochemistry professor at Stanford who, frustrated that little was being done to reduce the environmental impact of animal agriculture, decided to develop a competitive plant-based product.

Comparing the two products side-by-side and to a traditional beef burger shows they each have similar nutritional value. They all have about the same number of calories, the same amount of fat including saturated fat, and, interestingly, plant-based burgers have little more fiber than beef burgers.

They have become very popular very quickly although their sales pale in comparison to the real thing. Beyond Meat has its burgers in TGI Fridays, Carl’s Jr., A&W, Subway, and Dunkin, among others. They’re also in many chain markets such as Whole Foods, Safeway, and Giant.

Impossible Foods has an arrangement with Burger King, White Castle, the Hard Rock Café, Cheesecake Factory, Little Caesars, and others and is in many supermarket chains.

The Whopper is the icon of Burger King. If you compare the beef Whopper to an Impossible Burger, the calories (630 vs 680) are about the same. The beef burger has a bit more fat (34g vs 40g) but both have about the same amount of saturated fat (11g vs 12g).

The Impossible Whopper has more sodium (1080 vs 980), both have about the same amount of protein (25g vs 28g) and the same amount of sugar (12g vs 11g). Neither have much fiber (4g vs 2g). So, the basic reason to choose one of these burgers is to avoid beef and its impact on the environment, not because this Whopper is healthy, especially when paired with a large fries and a large soda.

A University of Michigan study commissioned by Beyond Beef suggests that “a cradle to distribution” life cycle assessment of these 4 oz burgers “generate 90% fewer greenhouse gases, require 46% less energy, has >99% less impact on water scarcity, and 93% less impact of land use than a ¼ pound pattie of US beef.” Impossible Foods did a similar study via Quantis with similar results.

The concept here is that to produce beef, a cow has to eat a large amount of grasses (and corn and soybeans in the feedlots), much more than what it takes to produce one of these plant-based burgers. And the cow releases a large quantity of carbon dioxide and methane into the atmosphere whereas plants consume carbon dioxide and release oxygen.

Both plant-based burgers taste good, have a good mouthfeel and in general, really do mimic a real beef burger. One of my physician friends says “I like them and I have one (the 4oz variety at stores) every few weeks at home. It’s a good meat substitute although I’m concerned it’s highly processed and I do worry about the high level of sodium. On the other hand, I do want to ‘save the planet’ and I think red meat, at least in excess, is potentially harmful.”

What’s next? Many countries like Germany and China are much more pork-oriented than beef. So, no surprise these companies are coming out with “pork” sausages, a stir-fried pork dish, and pork dumplings.

And of course, chicken is the mainstay in many fast-food restaurants so, again, no surprise that plant-based “chicken” bites are now available.

Although today these products are only a small fraction of the total meat market, there are those that believe that plant-based meat products could be a $450 billion dollar market within a few decades or less. Both companies are doing very well with increasing numbers of outlets for their products, so well that others have rapidly following suit.

Nestle’s, for example, introduced its “Awesome Burger” and as of Spring, 2021, has a greater market share than either Beyond or Impossible. Many others are pushing into the market.

One of the key questions is the balance between avoiding or reducing consumption of red meat and yet avoiding processed foods. John Mackey, the co-founder and chief executive officer of Whole Foods, one of the first chain organizations to market the Beyond Meat burger, made the following comment: these are “if you look at the ingredients, they are super highly processed foods.” “I don’t think eating highly processed foods is healthy. I think people thrive on eating whole foods.”

Mackey is a vegan and does believe in the concept of reducing animal protein in our diets if only to reduce greenhouse gas emissions. Consistent with his “whole foods” concept he is willing to sell them but not endorse them.

I always like the advice of Michael Pollan who, in the first sentence of his book In Defense of Food, wrote “Eat food, not too much, mostly plants.” By “food” he meant real food, not processed or junk.

Beyond Meat and Impossible Foods burgers are not meat but they are not whole plant food either. My take is, as with most foods, all things in moderation, except vegetables which we should eat in abundance.

These burgers are made exclusively from plant products but are extensively processed. Certainly, they reduce meat consumption and probably are not harmful. So, a good choice but on occasion. If you do like beef but want to avoid it, then this is a good possibility.

The Beyond Meat and the Impossible Foods’ burgers do mimic the real thing rather closely and, although slightly more expensive, with time the price will probably come down to beef price levels.

As for me, I will stick with having real beef burgers but not very often and preferably fresh ground and grilled by our grandsons. And as a treat, maybe toast up a marshmallow for dessert.

The post Where’s the Beef? appeared first on Medika Life.

The concept of breakthrough is when a fully vaccinated person later gets an infection. It is important to remember that not everyone responds to vaccines equally. The flu vaccine is a good example. Older people, for example, usually do not develop as great an immunity as do younger people. That is why in recent years the flu vaccine is given in a higher dose to those over 65. Still, the boosted vaccine does not prevent all flu infections. My wife and I learned from experience. A few years ago, a couple of months after getting the flu vaccine, we were at our favorite sushi restaurant and sitting at the sushi bar. The owner came by and said to us that they had a lot of their chefs developing what seemed to be the flu and she had sent them home. But there we were sitting directly across from where the chefs were working. A few days later we both woke up and knew exactly what we had.

The influenza vaccine, in a good year, tends to be about sixty percent effective. Meaning that about forty percent of people can still get infected if exposed even though they have been vaccinated. Fortunately, those who do get infected usually develop a less serious infection. That is still good. And even though the vaccine not 100% effective, it is still considered very valuable. It not only prevents infection in at last half of exposed persons but it also limits the spread so that many fewer get exposed.

In considering breakthrough infections, remember that the person who has been vaccinated almost certainly has some level of immunity. Therefore, the breakthrough infection is likely to be mild or even asymptomatic.

The COVID-19 vaccines are very effective. They prevent most people from getting a mild or moderate infection and they almost always prevent the development of an infection severe enough to lead to hospitalization and death. Many experts would say that these vaccines are way more effective than what was hoped for or even dreamed of nine months ago as the start of the large phase III trials.

To date, almost eighty million Americans have been fully vaccinated and less than ten thousand breakthroughs have been detected. Of course, that is so far. More will occur. If we look back to the original clinical trials that were presented to the Food and Drug Administration, the Pfizer-BioNTech vaccine had a ninety-five percent efficacy rate, the Moderna ninety-four percent, and the Johnson & Johnson sixty-six percent. AstraZeneca and Novavax will probably be presenting their data in the near future. Those vaccines will likely have very good efficacy rates as well.

Pfizer has now updated its information at six months. Remember, the data presented to the FDA in December had at least two months of information but now, at six months, the Pfizer vaccine is still doing well at ninety-one percent. To look back at the specifics, at two months the Pfizer large phase III clinical trials of some 44,000 volunteers found that, beginning two weeks after the second shot, in the placebo group there were 162 coronavirus infections whereas in the vaccinated group there were eight. Now at six months, the numbers are 697 in the placebo volunteers and fifty in the vaccinated group. So, there were some vaccinated individuals who developed infection, called a breakthrough infection, during those clinical trials.

What is your risk of a breakthrough? Low but real.

It is important to understand risk calculations. A 95% vaccine efficacy does not mean that five of every 100 vaccinated people will become infected. Remember that those Phase 3 clinical trials enrolled many thousands of individuals. In the Pfizer trial, for example, some 22,000 got the placebo and an equal number got the vaccine. At two months, 8 of the vaccinated volunteers developed symptomatic infection and by six months 50 have become infected, none with a need for hospitalization and no one died.

The first question to ask is, in this group, what was the risk of becoming infected? For the placebo patients in the Pfizer trial, it was about 0.8%. In other words, not all that many volunteers were exposed and hence were liable to become infected. Maybe, since they were volunteering in a study, they were also very careful to follow the guidelines for avoiding infection like masking and social distancing. But for those who were exposed. The vaccinated individuals had a very much lower (0.04%) but not zero risk of infection than did the placebo volunteers, hence the observed breakthrough infections.

The second question is to assess your own risk. Your risk would likely be higher if you are taking a medication that inhibits your immune response. Your risk might be somewhat higher if you frequent crowded bars, areas where the air exchange is limited or if you and others around you do not wear a mask or social distance. You might be living in an area where the infection is rampant versus someone living in an area where relatively few people are becoming infected. The risk is obviously going to be higher in the former than in the latter.

What are the numbers?

So far in the United States, most of the breakthrough infections have been mild but there have been a serious ones. In Washington state, as of March 30, after vaccinating 1.2 million individuals, there were 102 breakthrough infections or a risk of developing a breakthrough infection of 0.01%. Certainly, a small number. Of those 102, most were mild but eight people were hospitalized and two died. It is a message that says even with the vaccine, it is possible to become infected and it is possible, although remotely, to have a very severe infection.

In South Carolina, as of April 12, the Health Department has reported 155 breakthrough infections out of about 950,000 fully vaccinated residents or a rate of about 0.02%. In Oregon, as of April 8th, breakthrough infections occurred with three deaths among 700,000 fully vaccinated individuals for a rate of 0.024%.

In the Los Angeles area, two large health care providers, UCLA and USC, started doing weekly nasal swab tests on a proportion of their healthcare workers. Then, after some 15,000 staff at the two institutions were fifteen days post their second dose of either the Pfizer or Moderna vaccine, and with 4,167 of these tested weekly, there were seven individuals who tested positive for a rate of 0.05%. Some were asymptomatic and some symptomatic; none were serious.

The Centers for Disease Control, in a report dated on April 15th and which will be updated regularly, notes that with more than seventy-seven million Americans two weeks after full vaccination, 5,814 breakthrough infections have been reported across the country for a rate of 0.008%. The CDC points out that it is probable not all breakthroughs have been reported, certainly not all asymptomatic infections and probably not all mild infections. Still the risk rate is very low. It is worth noting however that most people have only been vaccinated for a few months at best. So, it is possible and in fact likely that, over more time, more of these breakthrough infections are be expected. Among the 5800 individuals, 396 were admitted to the hospital and 74 died although nine died for reasons other than from Covid-19.

Why do breakthroughs occur? The reasons are murky at best.

Certainly, older individuals and immunocompromised individuals may have a reduced immune response to the vaccine. The big clinical trials excluded those with a known suppressed immune condition so their responsiveness to the vaccines was not evaluated. But vaccines in general are known to be less effective in older individuals with lessened immunity, those on immune suppressing drugs and those with diseases or conditions that limit a strong immune response to a vaccine. An early study of kidney transplant patients showed that there was a very limited antibody response to the first dose of the Pfizer or the Moderna vaccine with most having no measurable response at all.

Some people may come in contact with a person exhaling a very high viral load which would be especially dangerous in a confined space. This might occur in a setting such as an elevator where someone who is infected is transmitting the virus in large numbers and this overwhelms the recipient’s immune response.

It is also possible that some of the variants such as the ones from the United Kingdom, South Africa or from Brazil are more transmissible and more dangerous in causing disease among vaccinated individuals. The authorized vaccines have been generally effective against the variants but not quite as good. Still, it is possible that breakthroughs may turn out to be more common with some of the variants. Only time will tell. The Centers for Disease Control is trying to determine for each person who has a breakthrough whether or not it is due to a variant or to the original strain.

For many, especially younger individuals with no underlying risk factors, the reasons why a breakthrough occurred are just not clear. As of now, many if not most people, cannot determine where they might have “caught it.” This means they are surprised and often stressed when they develop infection. As one person said, “I was supposed to be safe.”

Meanwhile, the CDC has posted recommendations on what fully vaccinated people should consider with regard to breakthroughs.

Should you worry? No.

But you should be proactive. Case counts are not down enough to be complacent; unfortunately, they are rising in many areas of the United States. This is just another reminder why it is still important to wear a mask, do social distancing, avoid crowded settings, avoid areas where there are limited air exchanges (like that elevator) and do wash your hands frequently. And if you are immunosuppressed from disease, frailty, medications, or advanced age, be extra careful. For all of us, it is important to remember that you are following these precautions for your own sake for sure but you are also doing it for the sake of others, especially the most vulnerable. We all need to be good neighbors.

The post Coronavirus Breakthrough Infections Are Not Common appeared first on Medika Life.