UK first country to authorize Pfizer-BioNTech vaccine for emergency use

 

• Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) have won permission for emergency use of their COVID-19 vaccine in Britain, with two doses three weeks apart required for protection. First in line are frontline health care workers and nursing home residents, followed by older adults.
• Calling the U.K. decision "a historic moment," Pfizer CEO Albert Bourla said, "we are focusing on moving with the same level of urgency to safely supply a high-quality vaccine around the world."
• Other countries aren't far behind: The U.S. and the EU also are vetting the Pfizer shot along with a similar vaccine made by competitor Moderna (NASDAQ:MRNA), and a similar nod by the FDA is expected as early as next week.
• While the U.K. has ordered enough Pfizer vaccine for 20M people, it's unclear how many will arrive by year's end and adding to the distribution challenges is that it must be stored at ultra-cold temperatures.
• British regulators also are considering another shot made by AstraZeneca (NASDAQ:AZN) and Oxford University.
• The shots made by Pfizer and BioNTech have been tested in tens of thousands of people and early results suggest the vaccine is 95% effective at preventing COVID-19. The vaccine has also been tested in only a small number of children, none younger than 12, but there's no information on its effects in pregnant women.
• https://seekingalpha.com/news/3640670-u-k-becomes-first-country-to-authorize-pfizer-biontech-vaccine-for-emergency-use

Mexico set to sign Pfizer vaccine deal

 Mexico’s government was due to sign a contract on Wednesday with pharmaceutical company Pfizer for the delivery of its coronavirus vaccine, Deputy Health Minister Hugo Lopez-Gatell said on Tuesday.

Pfizer has submitted the details about its vaccine to Mexico’s health regulator, Cofepris, and the country’s foreign minister last month said the government expects the vaccine to reach Mexico in December.

Lopez-Gatell said the contract with Pfizer, which developed its vaccine with German partner BioNTech SE, is expected to be signed by Health Minister Jorge Alcocer, and the Finance Ministry was making plans to ensure Mexico sets aside enough money to pay for the Pfizer and other vaccines.

Mexico’s contract with Pfizer will include ways to minimize the challenges associated with its vaccine, which requires that it be transported and stored at -70 degrees Celsius (-94 F).

“The contract that will be signed tomorrow includes provisions for its distribution to be as close to the point of use so that the period of deep freezing is shortened, the distance to be covered is shortened,” Lopez-Gatell said.

He said Mexico’s military will help with the vaccination process.

https://www.reuters.com/article/us-health-coronavirus-mexico-tally-vacci/mexico-set-to-sign-pfizer-vaccine-deal-on-wednesday-idUSKBN28C08P

U.S. CDC to shorten COVID-19 quarantine to 10 days

 The U.S. Centers for Disease Control and Prevention will soon shorten the length of self-quarantine recommended after potential exposure to the coronavirus to 10 days, or 7 days with a negative test, a federal spokesperson said on Tuesday.

CDC currently recommends a 14-day quarantine in order to curb the transmission of the virus.

https://www.reuters.com/article/us-health-coronavirus-usa-cdc-quarantine/u-s-cdc-to-shorten-covid-19-quarantine-to-10-days-federal-spokesperson-idUSKBN28C05D

US govt prepares for COVID-19 vaccine fraud surge

 With the first COVID-19 vaccines now nearing approval, the US government is preparing a crackdown on an anticipated spike in falsified and unauthorised medicines by fraudsters.

Homeland Security Investigations (HSI) – part of Immigration and Customs Enforcement (ICE) – is launching Operation Stolen Promise 2.0 in an attempt to identify and prevent the production, sale and distribution of illicit COVID-19 treatments and vaccines.

Organised criminals may well try to cash in on pent-up demand for vaccines in particular, tapping into public fears of missing out on the first wave of immunisations when supplies will be limited.

At the same time, many US states are worried they may not have the ancillary supplies they need to administer the shots – like needles, syringes and alcohol pads – which could impede the roll-out, according to a Government Accountability Office (GAO) report.

It’s quite possible that counterfeit versions of the first wave of vaccines – from the likes of Moderna and Pfizer/BioNTech – are already being produced by counterfeiters. Use of online pharmacies has already risen since the start of the pandemic, thanks to lockdown restrictions, and that raises the risk of exposure to a fake product.

HSI says it has been actively working with many of the leading pharmaceutical companies that are currently developing vaccines and treatments to try to minimise illicit sales.

Operation Stolen Promise 2.0 will try to disrupt and dismantle fraud schemes, removing illicit websites and other online marketplaces and seizing counterfeit or illicit vaccines and treatments. 

It is an extension of Operation Stolen Promise, which was launched in April as the pandemic was starting to gather momentum, and targeted financial aid fraud as well as counterfeit and unapproved products.

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Since the first operation started, ICE has seized more than $26m in illicit proceeds; made 170 arrests; executed 148 search warrants and analysed more than 69,000 COVID-19 domain names.

Working with US Customs and Border Protection, more than 1,600 shipments of mislabelled, fraudulent, unauthorised or prohibited COVID-19 test kits and other related items have been seized.

https://www.securingindustry.com/pharmaceuticals/us-govt-prepares-for-covid-19-vaccine-fraud-surge/s40/a12659/#.X8baYs1KjIV

Brazil sees one-dose, unfrozen vaccine as ideal for COVID-19

  A senior Brazilian Health Ministry official said on Tuesday that the ideal vaccine to immunize the country against COVID-19 would be one that could be stored at temperatures of a regular refrigerator and does not require multiple doses.

"Ideally it would be made in a single dose," said Health Surveillance Secretary Arnaldo Medeiros, although he recognized that was probably not possible.

Among the vaccines Brazil is considering for eventual purchase, the only single-dose option is the one being developed by Johnson & Johnson.

Medeiros, speaking at a ministry AIDS event, explained that Brazil's cold chain lacks the ultra-frozen capacity of wealthier nations. That would rule out the vaccine developed by Pfizer Inc in partnership with Germany's BioNTech SE, which needs to be transported and stored at -70 degrees Celsius and given in two doses about a month apart.

Pfizer has proposed building an extreme cold-storage chain using dry ice.

Moderna Inc's two-dose vaccine uses a similar technology as Pfizer's but can be stored at the more convenient temperature between 2 degrees and 8 degrees Celsius (36-46 F).

The Brazilian government has an agreement with British drugmaker AstraZeneca Plc to buy and produce a vaccine it is developing with Oxford University. Their two-dose vaccine, which can be easily transported and stored at normal fridge temperatures, would be made in Brazil by the government's Fiocruz biomedical center in Rio de Janeiro.

Sao Paulo state has a similar agreement with China's Sinovac Biotech to buy and eventually produce its two-dose CoronaVac vaccine, which can remain stable for up to 3 years while stored at between 2 to 8 degrees Celsius.

https://www.marketscreener.com/quote/stock/SINOVAC-BIOTECH-LTD-5714593/news/Brazil-sees-one-dose-unfrozen-vaccine-as-ideal-for-COVID-19-official-31914719/

Blueprint Medicines Says FDA Approves Gavreto to Treat Thyroid Cancer

 Blueprint Medicines Corp. on Tuesday said the U.S. Food and Drug Administration approved Gavreto as a treatment for certain types of thyroid cancer.

The company said the FDA approved Gavreto, or pralsetinib, as a treatment for patients with RET-altered thyroid cancers.

Blueprint Medicines said it is co-commercializing Gavreto in the U.S. with Genentech, under Blueprint's collaboration with Roche.

"In the Phase 1/2 ARROW trial, Gavreto showed durable efficacy and was generally well-tolerated in patients with RET-altered thyroid cancers with or without prior systemic therapy," Blueprint said.

"Earlier this year, the FDA granted accelerated approval to Gavreto for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer as detected by an FDA approved test," the company added.

https://www.marketscreener.com/quote/stock/BLUEPRINT-MEDICINES-CORPO-22033569/news/Blueprint-Medicines-Says-FDA-Approves-Gavreto-to-Treat-Thyroid-Cancer-31913750/

COVID-19 patients on some cancer therapies may be contagious for months

 COVID-19 patients who received cancer treatments that suppress their immune system may remain contagious and able to spread the coronavirus for two months or more, according to a study published on Tuesday.

The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that when patients have compromised immune systems, healthcare workers follow extra precautions such as wearing respirators instead of face masks and isolate patients for up to 20 days after symptoms appear.

In the new study, researchers analyzed sputum and swab samples from 20 immunosuppressed cancer patients infected with the new coronavirus. They found that three were contagious for more than three weeks after their symptoms began, including one who remained contagious for 61 days.

The three patients had received either a stem-cell transplant or therapy with genetically engineered immune cells called CAR T-cells within the previous six months. Two of the three had developed severe COVID-19. None of them had antibodies to the virus.

Current public health recommendations for COVID-19 patients with weak immune systems are based on limited data and may need to be revised, the researchers said in a letter published in the New England Journal of Medicine.

“We know from several studies that if you’re ... healthy, you are no longer infectious after the first week of illness. But there is very little we know about immunocompromised patients,” said Mini Kamboj, one of the study’s authors from the Memorial Sloan Kettering Cancer Center. “Is that 20 days enough or do we need to exercise precautions for longer than that?”

While only a small proportion of cancer patients with COVID-19 are likely to remain contagious for prolonged periods, “it’s a residual risk that we need to address,” Kamboj said. “We need to keep an open mind about how (much) longer immunocompromised patients could pose an infection risk to others.”

https://www.reuters.com/article/us-health-coronavirus-cancer/covid-19-patients-on-some-cancer-therapies-may-be-contagious-for-months-study-idUSKBN28B5S1