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J&J COVID Vaccine Factory Forced to Trash Even More Doses

Associated Press reported:

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.

Only Half of Eligible Americans Have Gotten Their First COVID Booster

ABC News reported:

As we approach the fall, there is a renewed push to get Americans vaccinated against COVID-19, particularly the elderly and the vulnerable, who continue to bear the brunt of the nation’s COVID-19 crisis.

Although over 61 million people, over the age of 50, are eligible to receive their second COVID-19 booster shot, just a third have actually done so, according to data from the Centers for Disease Control and Prevention.

Similarly, less than half of Americans, over the age of 5, who are eligible to receive their first booster have received their supplemental shot.

The CDC’s Confusing New Guidance for the COVID-Positive Is Actually Kind of a Relief

Slate reported:

The Centers for Disease Control and Prevention released new guidance on Thursday on how to live with the coronavirus. One of the recommendations, in particular, was surprising (OK, a lot were, but this one stood out): If you’re infected with COVID-19, you should isolate yourself for five days. Then, if you no longer have symptoms, you’re free to go out into the world, as long as you wear a mask — even if you are still testing positive on an antigen test.

Yes, really. Here’s what the guidance says: if after five days “your antigen test results are positive, you may still be infectious.” And so, to prevent spreading the virus, “You should continue wearing a mask.”

It’s also worth noting that the latest CDC guidance is an ever-more-complex tangle of options, and wild-card plays. For example, after five days, you have the option to go into the world (masked) but keep testing; if your test comes up negative sooner than day 10, you can remove your mask. But if COVID symptoms pop back up after five days, you need to go back into isolation and restart the countdown clock to day zero.

Also, none of this is relevant if you have shortness of breath: in that case, you should isolate for the full 10 days. At that point, you might also need to distinguish between shortness of breath due to light panic from all the instructions, versus COVID itself.

FDA: Take 3 Home Tests if Exposed to COVID to Boost Accuracy

Associated Press reported:

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.

Here’s Why Pharmacists Directly Prescribing Paxlovid Is No Quick, Easy Process Right Now

NBC Bay Area reported:

The antiviral drug that treats COVID-19, Paxlovid, must be taken within five days after symptoms begin. To expand quick access to the medication, the U.S. Food and Drug Administration revised the Emergency Use Authorization for Paxlovid in July to authorize state-licensed pharmacists to directly prescribe it.

Now more than a month after the FDA’s new authorization, it is still not easy for many eligible patients to get a Paxlovid prescription directly from their pharmacist.

It’s not just patients facing challenges. Many pharmacies may not be able to prescribe Paxlovid because of COVID-related staffing issues and how much extra time it takes to evaluate patients.

U.S. Monkeypox Cases Surpass 10,000 as CDC Still Aims for ‘Containment’

CBS News reported:

More than 10,000 Americans have now tested positive in the monkeypox outbreak across the U.S., according to figures published late Wednesday by the Centers for Disease Control and Prevention, as federal health officials say they are still racing to contain the virus.

Cases have been reported in every state but Wyoming while 15 states and the District of Columbia have reported more than a hundred cases. The largest numbers are in New York, California and Florida.

No U.S. deaths have so far been reported, out of the 12 monkeypox fatalities that the World Health Organization has tallied so far this year.

Health officials say the virus is mostly spreading through close interactions between men who have sex with men, either through direct skin-to-skin contact or shared linens like towels and bedding.

U.S. Colleges Lack Supplies to Prevent Monkeypox Outbreaks

Bloomberg reported:

Lack of access to monkeypox vaccines and tests threatens to hinder colleges and universities in the hardest-hit U.S. states as they plan to beat back a feared campus surge later this year.

Health administrators at schools nationwide are largely relying on educational measures as they prepare for the return of students for the fall semester. Some campuses have testing available at their medical centers, yet none reported requirements for students to get shots or undergo testing.

Germany: EU Could OK Combined COVID Vaccines Next Month

Associated Press reported:

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 on 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.

U.K. Decision Not to Buy COVID Drug Evusheld Disappoints Charities

The Guardian reported:

The U.K. will not buy the drug Evusheld, which can help prevent COVID infections in people with weakened immune systems, the government has said.

The decision, revealed on Friday in an official statement to BBC Radio 4’s Today program, has been met with criticism from a host of charities who say it means many people who are immunocompromised will be left with no option but to avoid contact with loved ones for fear of catching COVID.

The Department of Health and Social Care said the decision not to procure doses of Evusheld was down to a lack of data on the duration of protection offered by treatment in relation to the Omicron variant.