The new Omicron variant has President Biden and the CDC calling for vaccine boosters for everyone, even teens. What is the scientific basis for this?

Dr. Marty Makary, Johns Hopkins Medical School, questions the wisdom of this advice in an article just published in The Wall Street Journal. According to a large Israeli population study, published in The New England Journal of Medicine, the risk of Covid death in people under 30 with two vaccine shots was zero.

Since this study clearly was undertaken before the Omicron variant was widely spread, this reflects the impact of the more dangerous Delta or Alpha variants. The Omicron variant is clearly less dangerous as only one death has been reported to date in the U.K. and one recently in Texas. Yet the Omicron variant is now believed to be present in about 74% of new Covid infection cases. All this makes the danger of Covid-19 death in teenagers quite low, perhaps zero, especially if they have been vaccinated twice.

Why not just give them boosters anyway? Makary tells us there are infrequent, but real risks. In a study of 438,511 males 16 to 24, 56 developed myocarditis after their second Pfizer dose. That’s one in every 7,830 cases, or seven times the usual rate. While most cases were mild, in the broader group of 136 people including older and female patients, who developed myocarditis after the vaccine, seven had a “complicated course” and one 22-year-old died. The incidence of this complication is even higher with the Moderna vaccine, which is why some European countries have restricted it for people under 30.

But in the U.S., the FDA and the CDC are indiscriminately pushing for boosters for all young people. Some colleges are imposing booster mandates for all their students, despite the good health in most college students. Who made these recommendations?

Makary tells us the last vote by FDA scientific advisers, held in September, rejected the proposal 16 – 2. FDA leaders revisited the proposal in November and simply bypassed the experts they usually rely upon. The same is true of the CDC; their advisors also rejected boosters for people who were not at high risk. Two FDA top scientists, including the head of the agency’s vaccine efforts, resigned around the time of the September vote over White House pressure to authorize boosters for all. They wrote in detail about their concerns. (All this took place before the less dangerous Omicron variant was even the dominant virus.)

Now a study by Oxford researchers, published last week in Nature Medicine, has validated the concerns of these advisors. It found young people suffered myocarditis, pericarditis and arrhythmias more frequently from vaccines than from Covid itself. And the long-term cardiac effects of boosters in young people are unknown.

All of this seems to be coming in response to the Omicron variant. Although this variant is clearly more infectious, with doubling times now estimated at two to three days, the preliminary data thus far has shown it to be a mild, less dangerous variant. A University of Hong Kong study found that Omicron is less than one-tenth as infective in lung cells compared with the Delta variant. That explains why Omicron patients report far fewer cough and fever symptoms. Instead, they report common cold-symptoms, similar to the four known seasonal coronaviruses that have circulated for decades and account for the “common cold.”

Case counts are already plunging in South Africa, the epicenter of this new variant, and not one death has been reported there. South African Health Minister Joe Phaahla reports that only 1.7% of these Covid patients were hospitalized when this became the dominant variant as compared to 19% with the Delta variant.

With such a mild disease becoming the dominant variant, it would seem booster mandates, especially for young people, make little sense. They certainly would not be “following the science.”

Wow! I had no idea my blog was influencing the FDA! Within hours of my last blog, the FDA authorized both new oral antiviral drugs, Pfizer’s Paxlovid and Merck’s Molnupiravir. That’s just what I called for in my last post, Covid Therapeutics Taking a Back Seat. Seriously, I’m sure my blog had nothing to do with it; but it’s nice to see the government finally coming around to thinking like many physicians like myself. It’s great to push vaccines, which are very important, but therapeutic innovations like these two new oral treatments for Covid can be equally impressive in helping us return to some sense of normalcy.

But the news is not all good. Since the FDA was so slow to approve these drugs, and the Biden Administration was slow to appreciate their importance, these  pharmaceutical advances in therapeutics will be in short supply this winter. The Emergency Use Authorization (EUA) of the FDA is actually only for adults at high risk of severe illness. Both drugs will be available by prescription only with proof of a positive Covid test and should be taken within five days of symptom onset.

How do these drugs work? Both drugs interfere with virus replication, though by different means. Virus replication is the process of making more virus that leads to overwhelming the host. When drugs interfere with this process, they prevent the virus from spreading and the host immune system overwhelms the virus. Molnupiravir was found to reduce hospitalizations by about 30% and deaths by nearly 90%. Early results from its trial showed a 50% reduction in hospitalization, though efficacy declined later for unclear reasons. Paxlovid reduced hospitalization by about 90%.

Expect rationing of the drugs this winter. The Biden Administration ordered 10 million packs of Paxlovid in mid-November after strong preliminary trial results. But other countries have put in large orders, and Pfizer says it expects to manufacture 180,000 courses by the end of this year. Pfizer has licensed the drug to the Medicines Patent Pool to ramp up supply in lower-income countries, but production can take six to eight months. Advance government orders, like Operation Warp Speed for vaccines, might have accelerated production, says The Wall Street Journal.

The Biden Administration has ordered a mere 3.1 million treatment courses of Molnupiravir. The U.K. has purchased 2.2 million courses for its 68 million citizens. Most U.S. courses will be available by the end of January, but the FDA says the drug should only be used when other authorized treatments aren’t accessible or clinically appropriate. That means doctors are less likely to prescribe it.

The Wall Street Journal editorial board says, “Vaccines appear to have reduced the Biden Administration’s urgency to approve and accelerate new treatments, especially antivirals. Officials failed to foresee how vaccine efficacy would wane over time and demand would plateau. They can’t be faulted for that. But they could have hedged by fast-tracking oral treatments, as Operation Warp Speed did, by investing in multiple vaccine makers using different technology.”

The National Institutes of Health (NIH) also bears some of the blame. They bet heavily on monoclonal antibodies, which have been enormously helpful. But it overlooked the importance of other drugs for early treatment to prevent infected individuals from getting sicker. Early treatment therapeutics are the key to reducing hospitalizations. NIH was also late to fund a large trial on repurposing existing drugs such as the anti-parasitic ivermectin, anti-depressant fluvoxamine and asthma inhaling fluticasone. These drugs all show promising antiviral effects, but final results aren’t in yet.

We should celebrate the approval of these two new oral drugs to treat Covid, but it’s hard not to wonder how many more lives would have been saved if they had been approved earlier. WSJ says, “Vaccines have saved hundreds of thousands of lives, but many more would be saved if oral treatments like Paxlovid and Molnupiravir were available sooner. The drugs represent a huge pharmaceutical success but a missed government opportunity.”

If you watched President Biden’s latest speech on the Covid pandemic this week, you heard lots of talk about getting vaccinated. He repeated this mantra multiple times, making it a matter of morality and patriotism, as well as personal health. Although I’m very pro-vaccine, I also believe in America we have the freedom to make our own decisions about our bodies. Pro-choice advocates are always choosing this argument for women who choose abortion, but not so much when it comes to freedom to choose to be vaccinated or not. Then it’s our patriotic duty!

What’s missing from the conversation is any talk about viral therapeutics. It’s great to have effective vaccines, but it’s a big step forward to have effective therapeutics, too. Not everyone can be vaccinated, either for medical, religious, or personal reasons. Effective therapeutics make it possible to treat those who get infected anyway – and many of those may also have been vaccinated.

Perhaps it goes back to President Trump, who was vilified by the media for suggesting hydroxychloroquine was an effective treatment of Covid. Despite all the negative media about this drug, it has proven effective in limiting the severity and duration of Covid-19. Today, however, we have even better therapeutics.

I’ve written earlier about oral treatment of Covid-19. (Covid Pill Should be Coming Soon) That blog was written nearly three months ago and we’re still waiting for FDA approval.

Dr. Marty Makary, Johns Hopkins Medical School professor, writes in The Wall Street Journal that the FDA has been delinquent in authorizing both Merck’s and Pfizer’s antiviral pills that are designed to work against all Covid variants. Merck’s molnupiravir received an up-vote from FDA experts three weeks ago, yet the agency hasn’t authorized it. Pfizer’s paxlovid cut Covid deaths to zero (compared with 10 deaths in the control group), yet the FDA has been sitting on the application for five weeks without even scheduling an advisory meeting to review it. What are they waiting for?

There are other effective therapeutics, too. Fluvoxamine reduced Covid deaths by 91% among symptomatic high-risk patients in a second randomized controlled trial evaluating its effect. Yet there is little mention of this drug by public-health officials. Ivermectin is another drug that has been in use since 1996 for treatment of river blindness and other diseases caused by parasites. Its safety and effectiveness have been proven over 25 years. Ivermectin has also been found to be effective against 21 viruses, including Covid-19. A single dose of ivermectin reduced the viral load of Covid-19 in cells by 99.8% in 24 hours and 99.98% in 48 hours, according to a June 2020 study published in the journal Antiviral Research. In August, 2021, I wrote of some 70 clinical trials currently evaluating the use of ivermectin for treating Covid-19 patients. (FDA Withholding Effective Covid Drug) Yet we’ve heard nothing from public-health officials since that time.

Furthermore, we hear little about natural immunity and its impact on our society. Yet those who have survived Covid-19 have developed their own natural immunity, which has been estimated in one study in Israel to be 27 times as effective as vaccines in preventing future infection.

Dr Makary says, “Last week I testified before Congress that many Covid policies are no longer driven by science. Data is being cherry-picked to support predetermined agendas, while the roles of natural immunity and life-saving therapeutics are being sidelined.”

Vaccines are great, a monumental achievement of the Trump Administration’s Operation Warp Speed. The world is a much safer place because of them and I recommend them to all who can safely be vaccinated. But there is also much room for celebrating – and using – viral therapeutics. What could be easier than taking a home test for Covid, then a pill to get you over the next few days of what should be a common cold-like illness? Then, we could all get back to life as it was before Covid.