British drug regulators have become the first in the world to authorize an updated version of Moderna’s coronavirus vaccine that aims to protect against the original virus and the omicron variant.
In a statement on Monday, the Medicines and Healthcare Regulatory Agency said it had given the green light to Moderna’s combination “bivalent” vaccine, which will be used as an adult booster shot.
Each dose of the booster shot will target both the original COVID-19 virus that was first detected in 2020 and the omicron BA.1 variant that was first picked up in November. British regulators said the side effects were similar to those seen for Moderna’s original booster shot and were typically “mild and self-resolving.”
“What this (combination) vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve,” said Dr June Raine, the head of Britain’s health care and medicines regulator.
Such an approach is used with flu shots, which are adjusted each year depending on the variants that are circulating and can protect against four influenza strains.
Stephane Bancel, Moderna’s Chief Executive, said in a statement that it was the first regulatory authorization for a vaccine aiming to fight the omicron variant, predicting the booster would have an “important role” to play in protecting people against COVID-19 in the winter.
Britain’s health officials have not yet decided whether or not the tweaked vaccine will be used in its fall strategy. In July, the government said everyone 50 and over would get a COVID booster in the fall.
On Friday, Germany’s health minister said the European Medicines Agency might clear the tweaked COVID-19 booster next month.
In June, the U.S. Food and Drug Administration told vaccine makers that any booster shots tweaked for the fall would have to include protection against the newest omicron variants.
According to the World Health Organization, the latest global surge of COVID-19 has been driven by omicron subvariant BA.5, which is responsible about 70% of the virus samples shared with the world’s largest public virus database.
Germany’s health minister said Friday that European Union drug regulators may authorize the use of vaccines that are each effective against two variants of the coronavirus.
German Health Minister Karl Lauterbach said he expected the European Medicines Agency to meet Sept. 1 to consider a vaccine that would provide protection against the original virus and the omicron variant, also known as BA.1.
The EU agency would likely meet again on Sept. 27 to review a combined vaccine against the original virus and the BA.5 variant that is responsible for the latest global surge in COVID-19 cases, Lauterbach said.
Germany has procured sufficient amounts of both vaccines and would be able to start rolling them out a day after they received authorization, he said.
The U.S. Food and Drug Administration has said that combination vaccines, known as “bivalent” or “multivalent” shots, will allow boosters to retain the proven benefits of original coronavirus vaccines while providing additional protection against new variants.
Such an approach is used with flu shots, which are adjusted each year depending on the variants that are circulating and can protect against four influenza strains.
Lauterbach, a trained epidemiologist, said the potential for the coronavirus to keep mutating remained high.
“There are still very many variants that could develop,” he said, noting the large number of infections worldwide, including among people with weakened immune systems that allow the virus to persist for months.
Total Doses Distributed = 799,444,535. Total Doses Administered = 606,162,842. Number of People Receiving 1 or More Doses = 261,981,618. Number of People Fully Vaccinated = 223,457,170.
About 135 million more doses of Johnson & Johnson’s COVID-19 vaccine from a troubled Baltimore factory will have to be destroyed due to quality problems, Congressional panel leaders said Thursday.
The announcement follows a report in May that detailed how more than 400 million vaccine doses made at an Emergent BioSolutions plant had to be trashed. The doses more recently slated for destruction were made between August 2021 and February, the House members said.
Johnson & Johnson said in a statement Thursday that no doses produced at the site since the factory restarted have reached the market, and it was ending its agreement with Emergent.
The doses had been set aside after they were made. The panel said J&J told it that a batch of the shots failed inspection, which rendered all of them unusable.
The factory’s problems have hurt vaccinations in areas of the world where vaccines are still in short supply, said U.S. Rep. Jim Clyburn, a South Carolina Democrat and COVID-19 subcommittee chairman.
Emergent said it has been “open and forthcoming” about the factory’s challenges. It noted that J&J took control of the plant after problems first emerged and that J&J was in charge until manufacturing stopped there earlier this year.
The problem-plagued Baltimore factory was initially shut down by the Food and Drug Administration in early 2021 due to contamination. The government then allowed production to resume in August 2021.
J&J’s vaccine was one of three initially authorized by U.S. regulators more than a year ago to protect against COVID-19. But the government has since strictly limited who can receive the shot due to a small risk of rare but serious blood clots.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
If you were exposed to COVID-19, take three home tests instead of two to make sure you’re not infected, according to new U.S. recommendations released Thursday.
Previously, the Food and Drug Administration had advised taking two rapid antigen tests over two or three days to rule out infection. But the agency says new studies suggest that protocol can miss too many infections, and could result in people spreading the coronavirus to others, especially if they don’t develop symptoms.
The new guidance applies to people without symptoms who think they may have been exposed. People with symptoms can continue using two tests spaced 48 hours apart.
Thursday’s update reflects the evolving understanding of the accuracy of antigen tests, which are less sensitive than laboratory tests but have become the standard testing approach due to their speed and convenience. Instead of detecting the coronavirus itself, they detect protein traces, known as antigens, similar to rapid flu tests.
Health officials have repeatedly cautioned that the tests can give false negatives if taken too early. The Centers for Disease Control and Prevention recommends people without symptoms wait five days after an exposure. That’s because it generally takes several days before the antigens reach levels detectable via testing with a nose swab.
All 22 home antigen tests on the U.S. market were authorized for emergency use based on preliminary data, while companies and researchers gathered more definitive metrics on their accuracy.
The FDA said its latest decision reflects new information on the accuracy of antigen tests. In a government study, adding a third test improved accuracy from 62% to 79%.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
The nation’s top public health agency on Thursday relaxed its COVID-19 guidelines, dropping the recommendation that Americans quarantine themselves if they come into close contact with an infected person.
The Centers for Disease Control and Prevention also said people no longer need to stay at least 6 feet away from others.
The changes are driven by a recognition that — more than 2 1/2 years since the start of the pandemic — an estimated 95% of Americans 16 and older have acquired some level of immunity, either from being vaccinated or infected, agency officials said.
“The current conditions of this pandemic are very different from those of the last two years,” said the CDC’s Greta Massetti, an author of the guidelines.
The CDC recommendations apply to everyone in the U.S., but the changes could be particularly important for schools, which resume classes this month in many parts of the country.
Perhaps the biggest education-related change is the end of the recommendation that schools do routine daily testing, although that practice can be reinstated in certain situations during a surge in infections, officials said.
The CDC also dropped a “test-to-stay” recommendation, which said students exposed to COVID-19 could regularly test — instead of quarantining at home — to keep attending school. With no quarantine recommendation anymore, the testing option disappeared too.
Masks continue to be recommended only in areas where community transmission is deemed high, or if a person is considered at high risk of severe illness.
School districts across the U.S. have been scaling back their COVID-19 precautions in recent weeks even before the CDC relaxed its guidance.
Masks will be optional in most school districts when classes resume this fall, and some of the nation’s largest districts have dialed back or eliminated COVID-19 testing requirements.
Some have also been moving away from test-to-stay programs that became unmanageable during surges of the omicron variant last school year. With so many new infections among students and staff, many schools struggled to track and test their close contacts, leading to a temporary return to remote classes in some places.
The average numbers of reported COVID-19 cases and deaths have been relatively flat this summer, at around 100,000 cases a day and 300 to 400 deaths.
The CDC previously said that if people who are not up to date on their COVID-19 vaccinations come into close contact with a person who tests positive, they should stay home for at least five days. Now the agency says quarantining at home is not necessary, but it urges those people to wear a high-quality mask for 10 days and get tested after five.
The agency continues to say that people who test positive should isolate from others for at least five days, regardless of whether they were vaccinated. CDC officials advise that people can end isolation if they are fever-free for 24 hours without the use of medication and they are without symptoms or the symptoms are improving.
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Binkley reported from Washington, D.C.
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The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
