Roundup: COVID-19 Booster Shots Seem Likely; Rate of ‘Breakthrough’ Cases is Good News, CDC Says; and Latest on Vaccine Safety and Pregnancy

COVID-19 Booster Shots Could Be Reality Within 12 Months, Following by Annual Vaccinations

Infectious disease experts have said for months that “booster” shots of the COVID-19 vaccines will likely be necessary within a year after being fully vaccinated, and reports are now emerging that seem to make these annual shots a much more likely strategy.

Pfizer CEO Albert Bourla said people will “likely” need a booster dose within 12 months of getting fully vaccinated, especially as variant strains of COVID-19 continue to emerge through the U.S. and globally. The Pfizer-BioNTech vaccine, which requires two shots, three weeks apart, is one of three U.S. approved COVID-19 vaccines. The others are by Moderna, which requires two shots, four weeks apart, and the single-shot Johnson & Johnson, which is currently on pause as U.S. health agencies look into rare-but-serious blood clotting side effects.

“A likely scenario is that there will be likely a need for a third dose, somewhere between six and 12 months and then from there, there will be an annual revaccination, but all of that needs to be confirmed. And again, the variants will play a key role,” the Pfizer CEO, Mr. Bourla, told CNBC during an event with CVS Health.

 Moderna CEO Stephane Bancel told CNBC that the company “wants to make sure there are boost vaccines available in the fall so that we protect people as we go into the next fall and winter season in the U.S.”

Anthony Fauci, M.D., director of the U.S. National Institute of Allergy and Infectious Diseases, said the final decision on a recommended COVID-19 vaccine booster shot would be made by public health officials — not by pharmaceutical companies. In an interview on NBC’s “Meet the Press,” Dr. Fauci said: “It is going to be a public health decision. It is not going to be a decision that is made by a pharmaceutical company. We’re partners with them because they’re supplying it. It’ll be an FDA (U.S. Food and Drug Administration) and CDC (U.S. Centers for Disease Control and Prevention) decision.”

Moreover, David Kessler, M.D., who is on the Biden administration’s COVID response team told a congressional committee this month that Americans should expect booster shots to protect against coronavirus variants — but no boosters have been finalized or approved. There is no doubt that the variants present a challenge to existing vaccines, Dr. Kessler said. “So, I think for planning purposes, planning purposes only, I think we should expect that we may have to boost,” he added.

A third booster shot against COVID-19 has not yet been presented to U.S. public health agencies, but health experts emphasize boosters could be key to fighting COVID-19 variants that are beginning to spread widely across the U.S. from Brazil, South Africa and the United Kingdom.

CDC: So Far, 5,800 Fully Vaccinated People Have Gotten COVID-19, But That is Expected

They’re called “breakthrough cases” — referring to those who have been fully vaccinated against COVID-19 but have been infected anyway, according to the U.S. Centers for Disease Control and Prevention (CDC).

The CDC has released its first report on COVID breakthrough cases — as of April 13, 2021. As of that date, more than 75 million people in the United States had been fully vaccinated against COVID-19 since December 14, 2020. During the same time, CDC received 5,814 reports of vaccine breakthrough infections from 43 U.S. states and territories.

“COVID-19 vaccines are effective and are a critical tool to bring the pandemic under control,” the CDC states. “However, no vaccines are 100 percent effective at preventing illness. There will be a small percentage of people who are fully vaccinated who still get sick, are hospitalized, or die from COVID-19.”

The low number of breakthrough cases, compared to the 75 million people fully vaccinated, means that “these vaccines are working,” said CDC Director Rochelle Walensky, M.D., during a COVID-19 briefing on Monday. She added: “Here’s the bottom line, getting a vaccine will help protect you. It will help protect others and it will help us end this pandemic.”

Vaccine breakthrough infections were reported among people of all ages eligible for vaccination. Here’s a summary from the CDC’s report on breakthrough infections:

• 2,622 (45%) of the reported infections were among people 60 years of age or older.
• 3,752 (65%) of the people experiencing a breakthrough infection were female.
• 1,695 (29%) of the vaccine breakthrough infections were reported as asymptomatic.
• 396 (7%) people with breakthrough infections were known to be hospitalized and 74 (1%) died.

Of the 396 hospitalized patients, 133 (34%) were reported as asymptomatic or hospitalized for a reason not related to COVID-19. Of the 74 fatal cases, 9 (12%) were reported as asymptomatic or the patient died due to a cause not related to COVID-19.

“Hospitalizations and deaths that are not a direct result of COVID-19 are still considered vaccine breakthrough cases if the person was fully vaccinated and subsequently tested positive for COVID-19,” the CDC said.

The Pfizer-BioNTech’s vaccine was 95 percent effective in preventing symptomatic disease in clinical trials, and this month Pfizer-BioNTech reported that U.S. real-life data found the vaccine to be more than 91 percent effective against symptomatic disease for at least six months. Moderna’s vaccine was 94 percent effective in preventing symptomatic illness in trials, and 90 percent effective in real-life use. The Johnson & Johnson’s vaccine, which is currently on pause, was 72 percent effective at preventing COVID-19 in the U.S.

CDC: Preliminary Data Finds Pfizer, Moderna Vaccines Safe for Pregnant Women

Preliminary results from a large study of COVID-19 vaccinations during pregnancy confirms that they are safe — but researchers from the U.S. Centers for Disease Control and Prevention (CDC) although the authors say more comprehensive research is needed among pregnant women.

The preliminary findings, published this week in the New England Journal of Medicine, were derived from more than 35,000 U.S. women who received either the Pfizer-BioNTech or Moderna shots while pregnant. Rates of miscarriage, premature births and other complications were comparable to such published in studies on pregnant women prior to the pandemic.

From Dec. 14, 2020, to Feb. 28, 2021, a total of 35,691 pregnant women. Age distributions were similar among the participants who received the Pfizer–BioNTech vaccine and those who received the Moderna vaccine, with the majority of the participants being 25 to 34 years of age (61.9 percent and 60.6 percent for each vaccine, respectively) and non-Hispanic White (76.2 percent and 75.4 percent, respectively).

Injection-site pain, fatigue, headache, and myalgia were the most frequent local and systemic reactions after either dose for both vaccines — and were reported more frequently after second dose for both vaccines. The women who participated in the study were part of a voluntary smartphone-based vaccination surveillance system operated by the CDC. V-safe is a smartphone-based tool which allows users to text message or take part in surveys to provide the CDC with information on possible side effects from COVID-19 vaccines.

None of the women in the CDC study received Johnson & Johnson’s one-shot vaccine, which became available after the study, and now has been suspended by U.S. authorities as reported of blood clots in a small number of women are being investigated.