Tag Archives: one-dose

Factbox: Countries respond to heart inflammation risk from mRNA shots

(Reuters) – Some countries have halted altogether or are giving only one dose of COVID shots based on so-called mRNA technology to teens following reports of possible rare cardiovascular side effects.

Europe’s drug regulator said in July it had found a possible link between a very rare inflammatory heart condition and COVID-19 vaccines from Pfizer/BioNTech and Moderna.

However, the benefits of mRNA shots in preventing COVID-19 continue to outweigh the risks, European and U.S. regulators and the World Health Organization have said.

Here are some of the steps some countries are taking:

CANADA

The Public Health Agency of Canada said data suggested that reported cases of rare heart inflammation were higher after Moderna’s COVID-19 vaccine compared with the Pfizer/BioNTech shots.

SWEDEN

Sweden paused the use of Moderna’s COVID-19 vaccine for younger groups, citing data from a yet unpublished Nordic study.

The Swedish health agency said it would pause using the shot for people born in 1991 and later as data pointed to an increase of myocarditis and pericarditis among youths and young adults that had been vaccinated.

DENMARK

The Danish Health Agency said on Friday that it was continuing to offer Moderna’s COVID-19 vaccine to under-18s, and that a statement on Wednesday suggesting a suspension had in fact been a miscommunication.

FINLAND

Finland paused the use of Moderna’s vaccines for younger people and instead would give Pfizer’s vaccine to men born in 1991 and later. It offers shots to those aged 12 and over.

HONG KONG

A panel of health experts advising the Hong Kong government has recommended in September children aged 12-17 should get only one dose of BioNTech’s COVID-19 vaccine after reports of heart inflammation as a side effect.

NORWAY

Norway is giving one dose of Pfizer/BioNTech vaccine to children aged 12-15.

UNITED KINGDOM

Britain has been offering all 12-15-year-olds a first a shot of the Pfizer/BioNTech vaccine. Second doses would not be offered to the age group until at least spring when there may be more data from around the world.

(Compiled by Antonis Triantafyllou; Editing by Anna Pruchnicka and Tomasz Janowski)

FDA advisory panel to review Johnson & Johnson COVID-19 vaccine with thumbs up expected

By Manas Mishra and Michael Erman

(Reuters) – A panel of expert advisers to the U.S. Food and Drug Administration began a meeting to discuss Johnson & Johnson’s one-dose COVID-19 vaccine on Friday, setting the stage for a possible emergency use authorization as early as this week.

After it receives the recommendation, the FDA is likely to authorize the vaccine for emergency use within a day or so, making it the third available in the United States, and the only one that requires just one shot.

The panel, consisting of doctors, infectious disease experts and medical researchers, began the meeting at 9:00 a.m. ET (1400 GMT), and will vote in favor or against the vaccine’s use several hours later at the end of the meeting.

The panel will consider whether the benefits of the vaccine outweigh its risk for use in people aged 18 and older.

In a 44,000-person trial, the vaccine overall was 66% effective at preventing moderate-to-severe cases of COVID-19 compared with a placebo.

The effectiveness of the one-dose vaccine varied over time and location. In the United States, the effectiveness was 74% at 14 days and 72% two weeks later, while the shot was 64% effective at stopping moderate-to-severe COVID-19 after 28 days in South Africa, where a worrying new variant has swept across the country.

The vaccine was 100% effective at preventing hospitalizations 28 days after vaccination and there were no COVID-19 deaths among those who received the shot.

“In the context of the pandemic, the FDA is likely to issue an emergency use authorization (EUA) based on the data,” said UBS analyst Navin Jacob ahead of the panel meeting.

The J&J vaccine can be stored in normal refrigerator temperatures, making distribution easier than that of the Pfizer Inc/BioNTech SE and Moderna Inc vaccines that use mRNA technology and must be shipped and stored frozen.

J&J’s vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.

Three to four million doses of the vaccine are expected to be rolled out next week.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New York; Editing by Caroline Humer, Bill Berkrot and Shounak Dasgupta)