How Biden Officials Bungled a Better Vaccine

"How many times have public-health experts told us that Covid isn't like the flu? Suddenly that's changed. The Food and Drug Administration last week proposed treating the virus just like the flu when it comes to recommending annual vaccines.

There's a glaring problem with this strategy: Covid isn't seasonal. This virus has shown a remarkable ability to transmit year-round, with waves of infection occurring during summer as well as winter.

The mRNA vaccines boost protection against infection for a few months at best. A booster during the fall therefore may reduce your odds of getting sick for a few months -- though your protection depends on your immune response to the particular variants circulating. But as antibodies wane during the winter, you'll become susceptible again.

It's unclear that the potential risks of boosters for young, healthy adults and children exceed this small, short-term benefit. The elderly, who are at highest risk, might benefit on balance from boosters, but it's unreasonable to expect them to have to get them twice or more a year, as the FDA is proposing.

All of this underscores the folly of the government's promotion of Pfizer's and Moderna's mRNA vaccines at the expense of the one-dose shot by Johnson & Johnson, which most evidence suggests provides more durable immunity.

The Trump administration's Operation Warp Speed bet on six vaccine candidates that relied on different platform technologies, each of which came with advantages and drawbacks. A major benefit of the mRNA vaccines was their ability to be made rapidly, which was one reason they were the first to receive FDA authorization.

The mRNA vaccines also initially generated high levels of antibodies, which was why they demonstrated nearly 95% protection against symptomatic infection during randomized controlled trials.

Yet a major downside of these vaccines is that their antibodies ebb after a few months, leaving high-risk individuals vulnerable to infection and severe illness. One study from South Africa found that protection from two doses of the Pfizer vaccine against hospitalization during Omicron dropped from 80% about two weeks after inoculation to 19% nine months later.

J&J's vector vaccine is more difficult to manufacture, which slowed its rollout. It also initially generates a lower level of antibodies than the mRNA vaccines, which is why its single dose was only 72% effective in its trial. (Two J&J shots provided protection comparable to the mRNA two-dose regimen.)

But the J&J vaccine's antibodies are more durable, and its T-cell response is stronger. T-cells are important for protecting people from severe illness when antibodies wane -- and unlike antibodies, they aren't easily eluded by new variants.

A March 2022 study in the New England Journal of Medicine found that the killer T-cell response was five to 10 times as strong for the J&J vaccine as for the mRNA vaccines. Another study found that eight months after inoculation, neutralizing antibodies from the J&J vaccine were also five times as high as for the Moderna vaccine and 12 times as high as for Pfizer's.

This explains why protection against infection and hospitalization from the J&J vaccine has remained more stable over time. A study of North Carolina's 10.6 million residents showed J&J vaccine's protection against infection surpassing Pfizer after four months and Moderna after eight. Protection against death followed a similar trend. For people who don't want to get boosted every four to six months, the Johnson & Johnson vaccine looks to be the better shot.

But Biden administration officials used the discovery in April 2021 of a link between the J&J vaccine and a very rare but potentially life-threatening blood-clotting disorder known as thrombosis with thrombocytopenia syndrome to throw the shot under the bus. The Centers for Disease Control and Prevention estimated the risk at about 4 in a million and highest among women 30 to 49.

Such side effects need to be taken seriously. But the mRNA vaccines have safety risks too, not least myocarditis, especially for young men. An FDA study this month also found an increased risk of pulmonary embolism among seniors who had received the Pfizer vaccine. After the FDA initially played down a "statistical signal" linking Pfizer's bivalent booster to an increased risk of stroke, a CDC presentation last week revealed the risk may be real after all and appeared to be higher in seniors who had simultaneously gotten a high-dose flu shot.

Public-health authorities rushed to roll out the bivalent boosters in September despite having no clinical trial efficacy and safety data, partially because they believed uptake would be higher if seniors could get them at the same time as the flu shot. "God gave us two arms: one for the flu shot and the other one for the Covid shot," White House Covid czar Ashish Jha quipped during a press briefing.

Don't expect the Biden administration to acknowledge this blunder, or its mistake of promoting the mRNA vaccines over the Johnson & Johnson shot. Both errors stem from shortsighted calculations that don't properly weigh risks against benefits. The same goes for the annual booster push." [1]

1. Life Science: How Biden Officials Bungled a Better Vaccine
Finley, Allysia.  Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 30 Jan 2023: A.17.