FDA issues new COVID-19 testing guidance to avoid false negatives

New at-home COVID-19 antigen testing guidance recommends repeat testing after a negative result. [Image courtesy of Abbott]

COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers.

The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies from people likely infected by the omicron variant shows repeat testing increases the chance of an accurate result, reducing the likelihood of spreading the virus.

“At-home COVID-19 antigen tests detect proteins, called antigens, from the SARS-CoV-2, the virus that causes COVID-19,” the FDA said yesterday. “At-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests, such as polym…

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FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall

[Photo from Pexels]The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

FDA today followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.

Get the full story from our sister site, Drug Discovery & Development.

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FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall

Photo from Pexels

The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

FDA followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.

In particular, the agency recommends that vaccine makers develop bivalent COVID-19 vaccines with an omicron BA.4/5 spike protein component combined with the current vaccine composition.

FDA expects the updated vaccines to be used as a booster in “early to mid-fall 2022,” but the current formulation of vaccines for use as a primary series will remain unchanged.

Moderna and Pfizer have already shared data from c…

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Will COVID-19 vaccines be updated by fall? 

Photo by Frank Meriño from Pexels

FDA advisors are slated to meet to discuss the prospect of updating the first generation of COVID-19 vaccines for use as boosters this fall and winter.

But it remains unclear whether updating the COVID-19 vaccines will be necessary. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) have updated vaccines in the works.

Pfizer and Moderna have both said their next-generation vaccines appear to be more effective against the omicron BA.1 variant. But fighting the growing number of omicron lineages could prove challenging. For example, the recent emergence of BA.4 and BA.5 subvariants threatens those infected with older omicron variants.

Pfizer noted in a press release that it was developing monovalent and bivalent versions of its COVID-19 vaccine, developed jointly with BioNTech. Protection appeared to be substantially stronger against the BA.1 subvariant than the BA…

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Young children in U.S. now eligible for COVID-19 vaccination

Some 18 months after adults became eligible for COVID-19 vaccines, children between 6 months to 4 years old can now be vaccinated in the U.S.

FDA authorized the shots for young children on June 17, while CDC did so a day later.

“The United States is now the first country in the world to offer safe and effective COVID-19 vaccines for children as young as six months old,” said President Joe Biden in a press briefing. “And for the first time in our fight against this pandemic, nearly every American can now have access to life-saving vaccines.”

Biden noted that the U.S. government had ample supplies of vaccines for young children and had coordinated with states, local health centers, pharmacies and pediatricians to help administer the shots.

“My administration, with the help of the CDC, has been planning and preparing for this moment for a long time,” Biden said.

The federal government has also created a webs…

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Florida chooses to not pre-order COVID-19 vaccines for young children

[Image courtesy of Pixabay]

All U.S. states but Florida have pre-ordered COVID-19 vaccine doses for children under the age of 5, according to the Miami Herald. The federal government had a deadline of June 14 for states to pre-order vaccine doses.

In a statement, the Florida Department of Health said it decided not to order vaccine doses for young children because it does not recommend all children receive COVID-19 vaccines.

The statement also criticized the federal government’s COVID-19 track record. “States do not need to be involved in the convoluted vaccine distribution process, especially when the federal government has a track record of developing inconsistent and unsustainable COVID-19 policies,” it read.

Yesterday, an FDA advisory committee unanimously recommended emergency use authorization of COVID-19 vaccines in young children. Members of the committee, however, shared different opini…

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Sanofi-GSK next-generation COVID-19 booster could go head-to-head against revised Moderna and Pfizer offerings

Sanofi (Nasdaq:SNY) and GSK (NYSE:GSK) have announced that their next-generation COVID-19 booster vaccine candidate based on the beta variant yielded a substantial immune boost in adults previously primed with mRNA vaccines.

The novel vaccine yielded a strong increase in antibody titers above baseline against various variants of concern, including a 40-fold increase against the BA.1 omicron subvariant 15 days after vaccination. The same vaccine also yielded a 15-fold increase against the original D614 virus and a 30-fold increase against the beta strain.

The results were from two studies, the VAT02 Cohort 2 and COVIBOOST VAT013.

The new vaccine candidate elicited a more robust immune response than the Pfizer-BioNTech booster vaccine or the first-generation Sanofi-GSK vaccine candidate.

Last week, Moderna (Nasdaq:MRNA) also announced that its bivalent omicron booster vaccine candidate, mRNA-1273.214 yielded 1.75 times more neutralizing antibodies t…

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FDA considers possible myocarditis link in Novavax COVID-19 vaccine recipients

In reviewing clinical trial data related to the Novavax (Nasdaq:NVAX) COVID-19 vaccine, FDA expressed concerns about the product’s potential to cause myocarditis, a type of heart inflammation.

In a briefing document, FDA noted that the “identification of multiple potential vaccine-associated cases in a premarket safety database of ~40,000 vaccine recipients raises concern.” The agency goes on to say that if causally associated, “the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorization use of mRNA COVID-19 vaccines (for which no cases were identified in pre-authorization evaluation).”

In a statement, Novavax concluded that the rate of myocarditis and a similar condition known as pericarditis was similar across vaccine and placebo recipients. In the vaccine arm, 0.007% experienced such heart inflammation, while 0.005% of placebo recipients did.

Myocarditis is a risk occasionally ass…

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Emergent hid quality problems from FDA, House report concludes

A new Congressional report concluded that Emergent BioSolutions (NYSE:EBS) attempted to hide evidence related to quality problems before informing the FDA that 15 million COVID-19 vaccines were contaminated.

Prepared for Rep. Carolyn Maloney (D-NY) and James E. Clyburn (D-SC), the report from the House and the Select Subcommittee on the Coronavirus Crisis scrutinizes the quality controls in Emergent’s Bayview plant in Baltimore.

In particular, the House report concluded that Emergent workers removed quality-assurance “hold” tags from Johnson & Johnson vaccine batches before an FDA inspection.

The Bayview plant had served as the only U.S. manufacturing site for the J&J COVID-19 vaccine.

The report relies on internal communications from Emergent executives to determine whether the company attempted to elude government oversight.

It also noted that the FDA, J&J and AstraZeneca employees identified problems at the …

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FDA signals careful approach in authorizing COVID-19 vaccines in young children

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

Get the full story from our sister site, Drug Discovery & Development.

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FDA signals careful approach in authorizing COVID-19 vaccines in young children

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

The agency has tentatively scheduled three VRBPAC meetings for June 8, 21 and 22 to discuss offering the Moderna and Pfizer-BioNTech vaccines to younger children.

In addition, the FDA will meet to discuss the possibility of recommending modifying the strain composition of COVID-19 vaccines for the fall.

The VRBPAC is scheduled to meet on June 7 to discuss authorization of the Novavax vaccine in adults 18 and older.

The Novavax NVX‑CoV2373 vaccine has received conditional authorization from several regulatory authorities internationally. Its pr…

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AstraZeneca’s Evusheld offered strong protection against COVID-19 in Phase 3 study

In the Phase 3 Provent trial, Evusheld (AZD442) cut the risk of developing symptomatic COVID-19 by 77% in the primary analysis focused on patients at high risk for severe COVID-19. The monoclonal antibody cocktail, including tixagevimab and cilgavimab cut the risk by 83% in the six-month follow-up analysis compared to placebo. 

The drug is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19. 

Evusheld won a EUA in December 2021.

The adults enrolled in the trial had an inadequate response to COVID-19 vaccination, an elevated risk of exposure to SARS-CoV-2 or both. Subjects were either obese, immunocompromised, had pre-existing health conditions such as heart failure or chronic kidney disease, or were 60 years of age or older. 

After receiving a single 300 mg intramuscular dose of Evusheld, concentrations of the drug remained elevated for six months after administration, according to a pharmacokinetic analysis. 

Th…

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