FDA cautions against throat swab for at-home COVID tests

 The FDA is warning people to follow the instructions of at-home Covid-19 rapid tests and only swab their noses — pushing back against viral reports that the tests are more accurate when users also swab their throats.

The at-home rapid antigen tests currently available in the US were only developed and studied using nasal swabs. Swabbing your throat along with your nose could actually contaminate your sample, the FDA said.

“The FDA advises that COVID-19 tests should be used as authorized, including following their instructions for use regarding obtaining the sample for testing,” the agency, which approves Covid tests, told the Post in statement.

The FDA said it has also “noted safety concerns regarding self-collection of throat swabs,” which can harm a patient if done incorrectly and should be collected by a trained professional.

Despite the FDA recommendations, people are swabbing their throats because they don’t feel confident in the accuracy of at-home tests and think the Omicron variant, which often lives in the upper airways, might be more commonly found in throat.

Dr. Roy Gulick, chief of infectious diseases at Weill Cornell Medicine and NewYork-Presbyterian, said he isn’t surprised to hear people who experimented with at-home tests have found different results, but advised against “coloring outside the lines” when self-testing.

The FDA has warned at-home testing users to not swab their throats as it could contaminate the sample.

AP Photo/Denis Farrell, File

“The FDA has cautioned that the at-home tests can be less sensitive to pick up the Omicron variant,” he said “But that doesn’t mean they’re worthless.”

PCR tests remain the gold standard in the industry, but Gulick said early tests are an important starting points if available.

“Always start with a home test, and if it’s positive, certainly believe the result,” he said. “If it’s negative and you have classic covid symptoms or were in contact with someone who had Covid, the best thing to do is not to swab your throat but to go in and get the PCR test.”

The FDA has issued a stern warning after many social media users recommended swabbing throats for more accurate testing results.

Karen Focht/ZUMA Press Wire

Covid “is not a do-it-yourself disease,” Gulick said, and if you’re worried about accuracy, ignoring clinical instructions won’t help.

If anything, it’s this scramble to ensure accurate test results that emphasizes the importance of easy access to PCR testing.

“Early on when you’re not showing symptoms, you likely don’t have a lot of virus in your system, and rapid tests can’t pick up those low levels of virus,” Kara Cannon, the operations manager of Enzo Clinical Labs, which runs labs in the New York area that do Covid testing, previously told the Post. PCR tests, meanwhile, do take longer to process and require a lab but are able to capture smaller amounts of the virus.

Infectious diseases expert Dr. Roy Gulick argues the PCR COVID-19 test is the most accurate for detecting the bug.

Shawn Goldberg / SOPA Images/Sipa USA

Abbott, which manufactures the popular BinaxNow test, told the Post its tests remain “highly accurate” and said if users want to “ensure accurate test results, is important to follow the instruction for use” — stressing the test is only authorized by the FDA to work for a nasal sample.

But not everyone thinks a throat swab is a bad idea. Dr. Purvi Parikh, an immunologist at NYU Langone, thinks the throat swab is a good “add-on” to the nose swab.

“I would do both: nose first and then throat,” Parikh said. “If you’re sending out for a PCR and you’re able to do both, that’s helpful.”

Manufacturer Abbott says their at-home rapid test only works with a nasal sample.

William Farrington

Parikh says her suggestion stems from concerns that people aren’t swabbing themselves properly, failing to go deep enough in their nasal cavity and missing the virus.

Post-nasal drip from congestion might mean the virus will find its way into your throat, making it a useful site for sampling, she said.

For Brooklyn resident Jocelyn Silver, 29, a throat swab made the difference.

Silver, the managing editor at the website Gawker, began feeling sick on Monday but tested negative on a rapid antigen test. On Tuesday, a friend sent her a TikTok from a journalist suggesting you swab both your nose and your throat. Silver tried the method and tested positive.

“I can’t be making my medical decisions based on TikTok and I’m still planning on getting a PCR, but it seems like there’s some validity to it,” she said.

Still, she gets why the FDA is worried about people swabbing their own throats.

“It did make me gag and it was awful…I fully cried,” she said. “My landlord lives downstairs and she texted me and asked if everything okay.”

https://nypost.com/2022/01/04/fda-cautions-against-throat-swab-for-at-home-covid-tests/

Cullinan Oncology Gets FDA Breakthrough Tag for Lung Cancer Med

 Cullinan Oncology Inc. on Tuesday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to CLN-081 for the treatment of certain patients with non-small cell lung cancer.

The Cambridge, Mass., biopharmaceutical company said the designation covers CLN-081 in patients with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients harboring exon 20 mutations whose disease has progressed on or after prior therapy.

https://www.marketscreener.com/quote/stock/CULLINAN-ONCOLOGY-INC-117317644/news/Cullinan-Oncology-Gets-FDA-Breakthrough-Designation-for-CLN-081-37460353/

Spero Therapeutics Says FDA Lifts Clinical Hold on SPR720 Phase 2 Trial

 Spero Therapeutics Inc. said the U.S. Food and Drug Administration has lifted the clinical hold on the Phase 2 trial of SPR720, its investigational oral product candidate being developed for nontuberculous mycobacterial disease.

The SPR720 program was placed on a clinical hold by the FDA following a review of data from a non-human primate toxicology study in which mortalities with inconclusive causality to treatment were observed.

The company said the FDA's decision to lift the hold follows Spero's submission of a comprehensive study report with detailed analyses from the NHP toxicology study.

Spero plans on engaging with the FDA in the first quarter of 2022 to discuss the re-initiation of the SPR720 Phase 2 trial for NTM-pulmonary disease patients, with an expected study start date commencing in the second half of 2022.

https://www.marketscreener.com/quote/stock/SPERO-THERAPEUTICS-INC-38533873/news/Spero-Therapeutics-Says-FDA-Lifts-Clinical-Hold-on-SPR720-Phase-2-Trial-37461183/

Avrobio shares plummet as Fabry program axed, new trial starts slated for 2023

 Avrobio already trimmed expectations for its Fabry disease gene therapy in May because of Sanofi's Fabrazyme approval, and now the biotech is axing it altogether.

Enrollment in a phase 2 trial of AVR-RD-01 has been halted after new data found that five patients may be resistant to engraftment, or when new blood-forming cells begin growing to make healthy blood stem cells, the company said Tuesday. Previously, Avrobio had found durable engraftment in 13 patients across three clinical programs. The new data means the development of the gene therapy would be "meaningfully extended," CEO Geoff MacKay said. 

The executive also blamed challenges to the "market and regulatory environment" for the rare disorder as reasons for shutting down the program. 

Avrobio had planned to run a registrational trial in mid-2022 comparing the gene therapy to Fabrazyme, which gained full FDA approval last year after 18 years in the accelerated approval stage. Avrobio also wanted to take the accelerated pathway, but Fabrazyme's full approval altered those plans. 

“We’re fully aware of the impact this difficult decision has on the patients and families whom we have had the privilege to get to know over the years, but we believe deprioritizing and halting enrollment in our Fabry disease program is the right step forward for Avrobio and preserves our ability to continue developing therapies with the potential to address urgent unmet needs in the lysosomal disorder community," MacKay said.

Now, Avrobio will focus on a pipeline of other gene therapies to extend its cash runway into the first months of 2024. The company's stock slid 35% to $2.64 apiece as of 10:46 a.m. ET. 

With the shifted priorities, Avrobio will have a busy 2022 gearing up for multiple planned trial starts in 2023. The Cambridge, Massachusetts biotech will give an update on a phase 1/2 trial of AVR-RD-04 next month at the lysosomal diseases conference WORLDSymposium 2022. That gene therapy is being investigated for cystinosis, a rare disease characterized by an abnormal buildup of the amino acid cystine. Avrobio expects to speak with regulators about a mid-stage study. 

The biotech will also provide a clinical update in the next few months on its Gaucher disease type 1 therapy, AVR-RD-02, which is in a phase 1/2 trial in the U.S., Canada and Australia. Gaucher is an inherited disorder characterized by a missing enzyme that helps tear apart the fatty substance lipids, which leads to build-up in organs like the spleen and liver. 

Further down the line, Avrobio plans to ask regulators about a phase 2/3 clinical strategy for its gene therapy in Gaucher disease type 3, with could kick off in 2023. 

The biotech aims to begin two other trials that year: a phase 1/2 study of AVR-RD-05 for Hunter syndrome and an early-stage test of AVR-RD-03 in Pompe disease. 

https://www.fiercebiotech.com/biotech/avrobio-bids-adieu-to-fabry-program-adjusts-pipeline-to-focus-other-gene-therapies-multiple

Pfizer, GSK and Teva lead 2022's round of January drug price hikes: GoodRx

 One thing many pharma companies declined to include in their New Year's resolutions? Lowering the prices of expensive brand-name drugs. Within the first few days of the year, drugmakers have raised U.S. list prices on more than 400 meds, GoodRx reports.

So far in January, drugmakers have hiked the prices on 434 branded drugs by an average of 5.2%, the group reports. 

Pfizer is behind the largest number of price jumps, plus the steepest among any company. The company kicked off the New Year by dialing up the price tags of nearly 100 meds, ranging from a 0.5% jump on insomnia drug Halcion to a whopping 16.8% hike on immunology med Solu-Cortef.

Meanwhile, Pfizer bumped up the cost of pneumococcal shots Prevnar 13 and Prevnar 20 by 6.5% and 6.6%, respectively. The company's other drugs to get high-end price increases of 10% include the antibiotic Bicillin CR, the chemotherapy Camptosar, the estrogen-replacement therapy Depo-Estradiol and the anticoagulant Fragmin.

GlaxoSmithKline and Teva Pharmaceuticals each raised prices on more than 30 products. More than 20 price increases from generics juggernaut Teva landed well above the industry average at 9.4%, according to GoodRx. GSK's price bumps, meanwhile, ranged from 2% to 7%.

French drugmaker Sanofi, for its part, raised the list prices of 13 meds. They range from a 2.4% increase on its combination vaccine for diphtheria and tetanus, Pentacel, to a 5.2% increase on meningococcal vaccines Menactra and Menquadfi, plus typhoid fever preventative Typhim Vi.

Meanwhile, Gilead raised the prices on 11 meds—all by 5.6%.

Pfizer’s 16.8% price increase on Solu-Cortef marks the highest price increase so far this year. It’s trailed closely by Exeltis' birth control pill Tyblume, which saw its price jump 15.8%. Leadiant Biosciences’ cancer med Matulane climbed 15% on Jan. 1., as did Collegium Pharmaceutical’s pain drugs Nucynta and Nucynta Er.

Novartis upped the prices on just three drugs, Simbrinza, Signifor and Signifor Lar, by 5.3%, 5% and 5%, respectively, largely in line with the reported average.

One interesting pricing play came from BioMarin, Piper Sandler analysts wrote in a note to clients Tuesday. The price hikes, which “seem a bit more aggressive than years past,” could “provide for some moderate upside as 2022 progresses,” the analysts said.

The team flagged four BioMarin drugs: Brineura, whose price increased 3.5% versus 2% in 2021; Naglazyme, which has seen a 5% increase versus 2% in 2021; Palynziq, whose list price jumped 5.55% in 2022 versus last year’s 4%; and Vimizim, up 5% at the start of the New Year compared to 2% in early 2021.

So far, the January 2022 figure comes in below the 589 price hikes at a 4.2% average that GoodRx reported at the start of 2021. 2022's figures more closely resemble 2020's, when prices were raised on 463 drugs as of Jan. 3. But it's still early in January, so this month's numbers could climb.

https://www.fiercepharma.com/pharma/pfizer-gsk-and-teva-lead-2022-s-round-new-year-drug-price-hikes

UK officials: COVID boosters every few months not sustainable, necessary

 Health and science officials in the U.K. said on Tuesday that administering COVID-19 vaccine booster shots every few months is not necessary, though a short-term booster rollout to combat the spread of the omicron variant is needed.

During a news conference, Sir Patrick Vallance, the U.K.'s chief science adviser, said rolling out booster every few months is not a sustainable plan for combatting the pandemic, Reuters reported.

"It would be a situation that isn't tenable to say everyone's going to need to be having another vaccine every three or six months. That's not the long-term view of where this goes to," said Vallance, though he added that annual boosters, similar to the flu vaccine, may be necessary.

"We needed to get boosted for this variant at this moment. So I think there'll be a change over time and this will settle into a much more routine type of vaccine programme," Vallance said.

Sir Andrew Pollard, an Oxford professor who helped develop the AstraZeneca coronavirus vaccine, echoed Vallance's remarks, telling BBC Radio 4 that boosters multiple times a year was "not sustainable." Pollard also currently serves as an adviser on vaccines for the British government.

"It really is not affordable, sustainable or probably even needed to vaccinate everyone on the planet every four to six months," Pollard said. "We haven't even managed to vaccinate everyone in Africa with one dose so we're certainly not going to get to a point where fourth doses for everyone is manageable."

According to Pollard, booster shots for those with vulnerable immune systems may be needed, but said it was "unlikely" that one will be needed for the general population. Pollard, the director of the Oxford Vaccine Group, added that the U.K. may be in a better position pandemic-wise if future variants are milder as the omicron variant appears to be.

"There will be new variants after Omicron," said Pollard. "We don't yet know how they're going to behave — and that may completely change the view on what the right thing to do is."

https://thehill.com/policy/healthcare/588277-uk-officials-say-covid-19-boosters-every-few-months-not-sustainable

Abbott to sue Biden administration over vaccine mandate for National Guard

 Texas Gov. Greg Abbott (R) announced on Tuesday that he will sue the Biden administration to block the Pentagon’s vaccine mandate for his state’s National Guard.

In a letter to Maj. Gen. Tracy Norris, Adjutant General of the Texas Military Department, Abbott says he is suing because the federal government has put his state’s Guard members in a “difficult position.”

“As the commander-in-chief of Texas’s militia, I have issued a straightforward order to every member of the Texas National Guard within my chain of command: Do not punish any guardsman for choosing not to receive a COVID-19 vaccine,” the governor wrote.

“Although my order has been in effect for months now, President Biden has muddied the waters with a vaccine mandate from the U.S. Department of Defense,” he said.

The lawsuit comes weeks after Abbott formally told Defense Secretary Lloyd Austin that he would not impose the vaccine requirement for his state’s Guard members.  

Austin mandated vaccinations for the military in August, but each service is responsible for implementing the mandate.

Air National Guard members had until Dec. 31 to comply after the Air Force extended an earlier deadline. Meanwhile, Army National Guard members have until June 30 to be vaccinated. 

In October, Abbott ordered Norris not to punish any Guard members who choose not to receive the vaccine.

Abbott’s lawsuit also comes just a week after Oklahoma Gov. Kevin Stitt (R) lost a similar case to block the Pentagon’s vaccine mandate for National Guard members. 

Stitt was the first GOP governor to sue the Pentagon over the mandate in December, after Austin denied his request to exempt his state’s Guard members from the mandate. U.S. District Judge Stephen Friot said in a ruling last Tuesday that the claims made in that suit were “without merit.”

Meanwhile, five other GOP governors have urged Austin to exempt the National Guard from the vaccine mandate.

There are two federal statutes that dictate control of the National Guard. Abbott’s letter asserts that he holds authority over the Guard under Title 32 of the US Code, which stipulates that the Guard is under state control unless they are called up for federal duty. 

Under Title 10, the president can mobilize the Guard, placing them under federal authority. But the Austin has said that Guard members are federally funded when they receive training or education, so they must follow the mandate regardless.

“The federal courts have the power to decide whether President Biden violates the U.S. Constitution’s Second Militia Clause by undermining my commander-in-chief power, instead of federalizing Texas’s guardsmen to use his own commander-in-chief power,” Abbott wrote.

“Win or lose, President Biden must be held accountable for his unconscionable willingness to hollow out the Texas National Guard,” he continued.

The Hill has reached out to the Pentagon for comment. 

https://thehill.com/policy/defense/588202-abbott-sues-to-block-vaccine-mandate-for-national-guard