EXCLUSIVE: Trial Results Show Moderna Vaccine Continued to Be Safe and Efficacious More Than Five Months After Second Dose

Good news regarding Covid-19 has been rather scarce of late. But results from a Phase 3 clinical trial published today in the New England Journal of Medicine show that more than five months post-second injection, the Moderna (mRNA-1273) vaccine’s efficacy did not wane. These findings dramatically demonstrate the high level of protection COVID-19 vaccines are continuing to give us.

On a personal note, as a cancer patient, two-time Moderna vaccine recipient and advocate for Covid-19 patients and cancer patients, I am pleased to learn the results of this study.  

“Overall, our results continue to demonstrate that vaccines work and work extremely well at preventing COVID-19,” Dr. Lindsay Baden, the trial's co-corresponding author, said in a press statement.

Baden, who works in the Division of Infectious Diseases at Brigham and Women’s Hospital, said that researchers are continuing to explore questions about duration of immunity following vaccination and the impact of variants. Snd the news is largely good. Even as we examine the possibility of waning immunity, Baden said, "We see evidence that the vaccine is still very protective."

The peer-reviewed NEJM paper details the findings.  Starting 14 days after the second dose of the Moderna vaccine, the vaccine efficacy was 93.2 percent for the prevention of COVID-19 compared to placebo.  Prevention of COVID-19 remained consistent across the follow-up period, with greater than 90 percent vaccine efficacy against disease observed four or more months after the second injection.

 

"Safety data were assessed continuously throughout the trial, including severe adverse events. The team solicited data on local and systemic adverse events seven days after each injection and collected data on unsolicited adverse events 28 days after each injection," the study noted. 

 

The frequency of other adverse events — including severe adverse events — were generally similar between the vaccine and placebo group, regardless of age. Vaccine efficacy was consistently high in subgroups, including participants who were 65 and older, 75 and older, those with comorbidities, different racial and ethnic groups, and different categories of occupational risk exposures. 

 

In secondary analyses, researchers also found substantial protection against asymptomatic infection.

“Overall, our results continue to demonstrate that vaccines work and work extremely well at preventing COVID-19,” said Baden. “We are continuing to explore questions about duration of immunity following vaccination and the impact of variants. But even as we examine the possibility of waning immunity, we see evidence that the vaccine is still very protective.”

The trial enrolled 30,415 participants; 15,209 were assigned to receive the mRNA- 1273 vaccine, and 15,206 to receive placebo. Vaccine efficacy in preventing Covid-19 illness was 93.2%. The efficacy in preventing severe disease was 98.2%. 

And vaccine efficacy was consistent across ethnic and racial groups, age groups, and participants with coexisting conditions. No safety concerns were identified.

F. Scott Fitzgerald and The Great Gatsby: Thanks, Scott, For Showing Me How Powerful and Poignant the Written Word Can Be

F. Scott Fitzgerald

I wish The Great Gatsby wasn't required reading in so many high school English classes. When you're forced to read a book in school, you're far less likely to love it. When people ask me why I chose to write for a living, the most tangible answer I can come up with is The Great Gatbsy by F. Scott Fitzgerald. The book had a profound impact on me. 

Somehow, Gatsby continues to subtly influence my journalism, books, short stories and song lyrics. Gatsby showed me how powerful and poignant the written word can be.

F. Scott Fitzgerald is in my opinion America’s most indigenous and skilled writer. His poignant, powerful and uniquely American prose has no rival, and his themes resonate. They are utterly American. Although all four of his novels are excellent, Gatsby is perfection. It's a book that is both heartbreaking and redeeming. And yes, in many ways it is indeed the definitive American story.

 

I had a girlfriend in my college years who I called Daisy even though that was not her name. And she called me Jay. Yes, we were young, romantic and downright corny. But we were in love. With life, and literature, and each other. Of course, that relationship was destined to hit the rocks. And it did. But it shows you the impact a book and a writer can have on you. And nothing that happened to us was anything close to what happens in the book. After all, I am still alive and last I heard she is, too. 

With all the anger and division right now in this country, and the entire world, with the total lack of kindness or decency or grace, it's important to remember the goodness and greatness this country has produced, especially in our art.

America has produced some of the finest writers who ever lived. Significantly, that includes some amazing writers from the Deep South. You know, those red states that some of us are so mad at right now. 

F. Scott was a Yankee, but he married a woman from the Deep South. Zelda was a debutante, and she was Scott’s real-life Daisy. She rejected him at first, and only married Scott after  his first novel, This Side of Paradise, was published and he became a success. Sadly, she was mentally ill, and it got worse over the years.

Below is an interesting piece from Scott that I had not seen before called A Short Autobiography. It's from the May 25, 1929 issue of New Yorker magazine.

While it isn't an autobiography per se', it is telling and amusing. It's lightly comic, but it's alcohol-soaked and a sad glimpse of what was to become of Scott, who died in the most undignified of ways and places: in an apartment off the Sunset Strip in Los Angeles, which has been known to destroy numerous novelists.

It was Dec. 21, 1940. Scott had a fatal heart attack in the apartment of gossip columnist Sheilah Graham. He should have died many years later, and in a much more dignified way. Say, in Paris outside a bistro, or while walking the streets of Greenwich Village in Manhattan. But not in Hollywood.

But that may be the most significant lesson a writer ultimately faces. Unlike in his novels and short stories, where he could choose where the characters lived, loved and died, Fitzgerald had no control over when and how he passed. It just doesn't work that way in real life. 

 

And there's the rub. Real life is something that many of our great writers and artists have tangled with and lost.

 

Personally, I have never had that problem. I embrace life, always have. Not every day is a good day, and I have battled cancer three times. Life can be a son of a bitch. But I have always had a love for life. It's good just to be alive. It's a gift. I really believe this, and most days I live my life that way. 

 

I wish more of our writers and other artists could realize that the beauty and joy in their work can also inhabit their lives, if they let it. I guess that's easier said (or written) than done. 

Regardless, Scott, I extend to you a sincere thank you for inspiring me throughout my life and for your perfect prose.

A Short Autobiography

By F. Scott Fitzgerald

May 17, 1929

(WITH ACKNOWLEDGEMENTS TO NATHAN)

1913

The four defiant Canadian Club whiskeys at the Susquehanna in Hackensack.

1914

The Great Western Champagne at the Trent House in Trenton and the groggy ride back to Princeton.

1915

The Sparkling Burgundy at Bustanoby’s. The raw whiskey in White Sulphur Springs, Montana, when I got up on a table and sang, “Won’t you come up,” to the cowmen. The Stingers at Tate’s in Seattle listening to Ed Muldoon, “that clever chap.”

1916

The apple brandy nipped at in the locker-room at the White Bear Yacht Club.

1917

A first Burgundy with Monsignor X at the Lafayette. Blackberry brandy and whiskey with Tom at the old Nassau Inn.

1918

The Bourbon smuggled to officers’ rooms by bellboys at the Seelbach in Louisville.

1919

The Sazzarac Cocktails brought up from New Orleans to Montgomery to celebrate an important occasion.

1920

Red wine at Mollat’s. Absinthe cocktails in a hermetically sealed apartment in the Royalton. Corn liquor by moonlight in a deserted aviation field in Alabama.

1921

Leaving our champagne in the Savoy Grill on the Fourth of July when a drunk brought up two obviously Piccadilly ladies. Yellow Chartreuse in the Via Balbini in Rome.

1922

Kaly’s crème de cacao cocktails in St. Paul. My own first and last manufacture of gin.

1923

Oceans of Canadian ale with R. Lardner in Great Neck, Long Island.

1924

Champagne cocktails on the Minnewaska, and apologizing to the old lady we kept awake. Graves Kressman at Villa Marie in Valescure and consequent arguments about British politics with the nursery governess. Porto Blancs at a time of sadness. Mousseux bought by a Frenchman in a garden at twilight. Chambéry Fraise with the Seldes on their honeymoon. The local product ordered on the wise advice of a friendly priest at Orvieto, when we were asking for French wines.

1925

A dry white wine that “won’t travel,” made a little south of Sorrento, that I’ve never been able to trace. Plot coagulating—a sound of hoofs  and bugles. The gorgeous Vin d’Arbois at La Reine Pédauque. Champagne cocktails in the Ritz sweatshop in Paris. Poor wines from Nicolas. Kirsch in a Burgundy inn against the rain with E. Hemingway.

1926

Uninteresting St. Estèphe in a desolate hole called Salies-de-Béarn. Sherry on the beach at La Garoupe. Gerald M.’s grenadine cocktail, the one flaw to make everything perfect in the world’s most perfect house. Beer and weenies with Grace, Charlie, Ruth, and Ben at Antibes before the deluge.

1927

Delicious California “Burgundy-type” wine in one of the Ambassador bungalows in Los Angeles. The beer I made in Delaware that had a dark inescapable sediment. Cases of dim, cut, unsatisfactory whiskey in Delaware.

1928

The Pouilly with Bouillabaisse at Prunier’s in a time of discouragement.

1929

A feeling that all liquor has been drunk and all it can do for one has been experienced, and yet—“Garçon, un Chablis Mouton 1902, et pour commencer, une petite carafe de vin rose. C’est ça—merci.”

Breaking News: New Study Shows That Most Blood Cancer Patients Benefit From Third COVID-19 Vaccine

This pandemic has been traumatic for all patients whose immune systems are compromised, including cancer patients. But perhaps no one group of cancer patients has been more concerned about or affected by Covid-19 than blood cancer patients. 

As I recently reported for Healthline, a study from the Leukemia and Lymphoma Society (LLS) found that 25 percent of blood cancer patients are not getting any antibodies from the Covid-19 vaccines. As a three-time survivor of non-Hodgkin's lymphoma, this news of course resonated with me and with my fellow lymphoma survivors. 

 

But there is some good news that we can now announce. 

In a new study published in the journal Cancer Cell, LLS researchers found that more than one in two patients with B-cell blood cancers produced antibodies after a third dose of COVID-19 vaccine despite having no detectable antibodies after the first two doses. 

The study also showed that patients who had detectable antibodies after the first two vaccine doses had increased levels after the third dose. 

In an exclusive interview, Dr. Gwen Nichols, Medical Director of LLS, told The Reno Dispatch, "Our findings are encouraging for patients with blood cancer, since the additional COVID-19 vaccine dose seems to improve immune response in many. But some blood cancer patients will still not mount a full response even with the extra dose, so our message remains the same."

She noted that If you have blood cancer, you are at increased risk of serious illness and death from COVID. "Get vaccinated and layer on additional precautions like masking and social distancing to stay safe," she said. 

LLS recommends that blood cancer patients who received two doses of either Moderna or Pfizer mRNA vaccine get an additional dose according to the Centers for Disease Control and Prevention (CDC) guidance for people who are moderately to severely immunocompromised. 

CDC has indicated that additional guidance will be coming soon for patients who received Johnson & Johnson’s Janssen COVID-19 vaccine. 

Until then, patients who received J&J or any other non-mRNA vaccine should consider an additional dose and talk to their healthcare provider. 

LLS also advises all blood cancer patients to continue to layer on additional precautions like masking and social distancing to avoid becoming infected. 

Based on pre-vaccine data, patients with blood cancer tend to have more prolonged and severe COVID-19 infections compared to their healthy counterparts, including having significantly higher rates of death.  

Dr. Lee Greenberg, LLS Chief Scientific Officer, explained to The Reno Dispatch that there can be multiple reasons why a patient with no antibodies will produce antibodies after booster vaccination.  

"One reason is that the B-cell suppressive effect of anti-CD20 Ab, which can last for months after the initial therapy, have dissipated," he said, adding that normal B-cell function can start to return in 6-9 months, but full recover could require more than 1 year.

"A second reason is that some patients have either discontinued the BTK inhibitor therapy or taken a reduced dose prior to booster vaccination," he said.

Another reason that this can happen is because the disease is under control and normal B-cell function has returned, he said.

And lastly, Greenberg explained, "Antibodies to SARS-CoV-2 are in the normal blood supply; those patients getting infusions of antibodies can acquire spike and nucleocapsid antibodies from the donor."

Treatment with the antibody Rituxan 6 to 12 months prior to vaccination was associated with a failure to produce detectable COVID-19 antibodies, even after a third dose of the mRNA vaccines. 

In addition, some patients being treated with Bruton tyrosine kinase (BTK) inhibitors also fail to make detectable COVID-19 antibodies, though individual results in BTK inhibitor patients were more variable. 

Current cancer treatment guidelines do not call for pausing these treatments or delaying COVID-19 vaccination in blood cancer patients. 

The best path forward is for blood cancer patients to consult with their health care team and to get vaccinated and to continue practicing other important infection prevention procedures recommended by the CDC, say LLS experts.

An earlier study of more than 1,400 blood cancer patients enrolled in the LLS National Patient Registry reported that about one in four fail to produce detectable antibodies after two doses of either Moderna or Pfizer mRNA COVID-19 vaccines. 

However, these rates vary by cancer type, with non-Hodgkin's Lymphoma (NHL) and chronic lymphocytic leukemia (CLL) patients less likely to have detectable antibodies. 

Patients with these forms of cancer have a diminished response to vaccination because NHL and CLL can deplete the body’s B-cells. The body needs healthy B cells to fight infections and also to mount an antibody response to the vaccines.

Among the 38 patients with B-cell derived malignancies (almost all had NHL or CLL) in this latest study who were seronegative after two vaccine doses, 21, or 55%, had detectable antibodies after the third dose while 17 patients (45%) remained seronegative. 

The 11 patients in the study who had measurable antibodies after the first two doses all had increased antibody levels after the third dose. Even in this difficult-to-immunize population, the study shows the majority (32 of 49, 65%) have detectable antibodies.

“Antibody levels in our study ranged from 2.2 to over 2,500,” said Greenberger.

"Antibodies tell us that a patient has responded to vaccination—and that is a positive finding, but vaccine experts are still working to determine exactly what antibody level is needed to protect against COVID-19 infection or its worst outcomes.”

Greenberger and his colleagues, including Dr. Larry Saltzman, LLS Executive Research Director, are working on another study assessing blood cancer patients’ T-cell response to vaccines. 

The immune system’s T-cells are primed by vaccination to create “killer cells,” which are the first line of defense against infections like COVID-19. They are also analyzing antibody data from hundreds of additional patients who have received a third vaccine dose. 

T-cell results and an update to the current study are both expected later this year.

Based on the results of this and the earlier LLS study, the society estimates that at least 100,000 blood cancer patients in the U.S. will not have detectable antibodies following three doses of mRNA vaccines.