Major U.S. airlines will voluntarily collect international contact tracing info

 

Major U.S. airlines on Friday said they would adopt a voluntary international contact tracing program, months after the White House under then-President Donald Trump blocked a mandatory effort.

American Airlines, Delta Air Lines, Southwest Airlines, United Airlines and other major airlines said they had committed to collecting contact tracing data from passengers traveling into the United States and to relaying that data to the Centers for Disease Control and Prevention (CDC) if travelers provide information.

In August, Trump officials rejected an effort to require airlines to collect contact tracing information from U.S.-bound international passengers after some senior administration officials cited privacy concerns, Reuters reported.

Major airlines and administration officials had held talks for months over a long-standing CDC effort to mandate the collection and reporting of tracing information from international passengers.

In February 2020, the CDC issued an interim final rule to require airlines to collect five contact data elements from international passengers, including phone numbers, and electronically submit them to Customs and Border Protection to facilitate contact tracing. But the rule was never enforced.

Airlines protested, arguing they could not provide such information, especially from passengers booking tickets through third-party websites. Airlines backed setting up a website and a mobile application for passengers to send contact information directly to the CDC.

Nick Calio, who heads airline trade association Airlines for America, said airlines were hopeful the voluntary effort and COVID-19 international passenger testing requirements adopted last month by the CDC "will lead policymakers to lift travel restrictions."

President Joe Biden in January reimposed an entry ban on nearly all non-U.S. travelers who have recently been in Brazil, the United Kingdom, Ireland and 26 countries in Europe that allow travel across open borders that Trump had sought to end - and quickly added South Africa to the list.

There is no immediate indication the CDC will move quickly to drop those restrictions, some of which have been in place for almost a year.

https://www.marketscreener.com/quote/stock/AMERICAN-AIRLINES-GROUP-I-15171667/news/Major-U-S-airlines-will-voluntarily-collect-international-contract-tracing-info-32482763/

Dr.Reddy's seeks Indian emergency use authorization for Russia's Sputnik V vaccine

 Indian drugmaker Dr.Reddy’s Laboratories said on Friday it has begun the process of filing for emergency use authorization of Russia’s Sputnik V COVID-19 vaccine in India.

If approved, Sputnik V, developed by Moscow’s Gamaleya institute and marketed abroad by the Russian Direct Investment Fund (RDIF), will have the highest efficacy of vaccines currently cleared for emergency use in India.

AstraZeneca’s shot - which is manufactured by Serum Institute of India under the COVISHIELD brand name - and Bharat Biotech’s vaccine, COVAXIN, are the other two vaccines cleared for emergency use in the country.

The approval of the Sputnik V vaccine would bolster India’s immunisation campaign, which on Friday crossed the 10 million mark. The country aims to inoculate 300 million people by August.

Dr.Reddy’s has been working with RDIF to hold small domestic clinical studies of Sputnik V.

The vaccine has proved to be 91.6% effective against COVID-19 based on late-stage trials in Russia, a figure that has been confirmed by peer-reviewed results in The Lancet medical journal.

The drugmaker said it would present the safety profile of a mid-stage study and interim data from a late-stage trial, which is expected to be completed by Feb. 21, to the Drugs Controller General of India.

Shares of the company, which had fallen as much as 1.9%, reversed course to trade 1.4% higher following the news.

For comparison, Bharat Biotech is yet to release efficacy data for COVAXIN, while AstraZeneca’s vaccine has an efficacy of around 60%.

https://www.reuters.com/article/us-health-coronavirus-india-dr-reddys/dr-reddys-seeks-indian-emergency-use-authorization-for-russias-sputnik-v-vaccine-idUSKBN2AJ116

White House working with Facebook and Twitter to tackle anti-vaxxers

 The White House has been reaching out to social media companies including Facebook, Twitter and Alphabet Inc’s Google about clamping down on COVID misinformation and getting their help to stop it from going viral, a senior administration official said.

President Joe Biden, who has raced to curb the pandemic since taking office, has made inoculating Americans one of his top priorities and called the move “a wartime effort.” But tackling public fear about taking the vaccine has emerged as a major impediment for the administration.

Since the onset of the pandemic, calls from lawmakers asking the companies to tackle the spread of COVID misinformation on their platforms have grown.

The White House’s direct engagement with the companies to mitigate the challenge has not been previously reported. Biden’s chief of staff Ron Klain has previously said the administration will try to work with Silicon Valley on the issue.

“Disinformation that causes vaccine hesitancy is going to be a huge obstacle to getting everyone vaccinated and there are no larger players in that than the social media platforms,” said the source, who has direct knowledge of the White House’s efforts.

“We are talking to them ... so they understand the importance of misinformation and disinformation and how they can get rid of it quickly.”

The Biden White House is especially trying to make sure such material “does not start trending on such platforms and become a broader movement,” the source said.

The source cited the example of the anti-vaccine protests at Dodger Stadium in Los Angeles in early February, and said the White House wants to stop events like that from happening again.

The protest, organized on Facebook through a page that promotes debunked claims about the coronavirus pandemic, masks and immunization, briefly blocked public access to the stadium - one of the largest vaccination sites in the country, where health authorities are administering more than 8,000 vaccines a day.

The event illustrated the extent to which social media platforms have become a critical organizing tool for movements such as the anti-vaccine drive, that spread misinformation and disinformation.

A growing number of anti-vaccine activists, emboldened by their rising social media following, have helped the movement gain strength in the United States. A report by the Center for Countering Digital Health in July 2020 found social media accounts held by anti-vaxxers have increased their following by at least 7·8 million people since 2019.

The companies have repeatedly vowed to get rid of such material on their platforms but gaps remain in their enforcement efforts.

On Thursday, Senator Richard Blumenthal criticized the platforms in a tweet for carrying ads that he said funds and promotes “dangerous conspiracy theories, COVID-19 disinformation and malign foreign propaganda.”

A Facebook spokeswoman said that the company has reached out to the White House to offer “any assistance we can provide” and has recently announced a new policy to remove COVID and vaccine misinformation along with pages, groups, and accounts that repeatedly spread such material.

A Twitter spokesman said the company is “in regular communication with the White House on a number of critical issues including COVID-19 misinformation.”

Alphabet Inc’s Google did not comment on engagement with the White House, instead pointing to a company blog on and how it stops misinformation.

The source said the companies “were receptive” as they engaged with the White House. “But it is too soon to say whether or not it translates into lessening the spread of misinformation.”

There will be more details on how the White House is engaging with the social media companies on this issue in the “next ten days or so”, the source added.

https://www.reuters.com/article/us-health-coronavirus-white-house-exclus/exclusive-white-house-working-with-facebook-and-twitter-to-tackle-anti-vaxxers-idUSKBN2AJ1SW

Pfizer seeks U.S. approval to ease handling of COVID-19 vaccine

 Pfizer Inc and BioNTech SE have submitted new temperature data to the U.S. health regulator which they said on Friday could allow their COVID-19 vaccine to be stored in pharmacy freezers rather than in ultra-cold storage facilities.

If approved, the less onerous storage requirements would provide a significant logistical relief for the roll-out of the vaccine, particularly in lower-income countries that do not have the necessary infrastructure.

Pfizer/BioNTech’s vaccine, along with Moderna Inc’s two-dose shot, won the U.S. emergency use authorization (EUA) and is being widely distributed as part of the country’s mass vaccination efforts.

The new data has been submitted to the U.S. Food and Drug Administration to support a proposed update to the current EUA label that would allow vaccine vials to be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks as an alternative for storage in an ultra-low temperature freezer.

“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” BioNTech Chief Executive Officer Ugur Sahin said.

Pfizer/BioNTech’s current label requires the vaccine to be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), calling for it to be shipped in specially designed containers.

The new data also will be submitted to global regulatory agencies within the next few weeks, the two companies said.

A BioNTech spokeswoman declined to provide more details on the timing and which agencies would be contacted.

https://www.reuters.com/article/us-health-coronavirus-pfizer/pfizer-seeks-u-s-approval-to-ease-handling-of-covid-19-vaccine-idUSKBN2AJ1CJ

Israel data suggest one dose of Pfizer vaccine could be less effective than expected

 Concerns have been raised over how much protection a single dose of the Pfizer BioNTech covid-19 vaccine provides, following reports from Israel that it is much lower than expected.

Israel, which, like the UK, is currently in its third national lockdown, has so far vaccinated more than 75% of its older people with at least one dose. Early reports from the vaccine rollout have suggested that the first dose led to a 33% reduction in cases of coronavirus1 compared with efficacy of at least 52% reported in clinical trials.2

A preliminary report from the Clalit Research Institute compared the infection data of 200 000 people aged 60 and over who were not vaccinated with the infection data of 200 000 people of the same age group who received one vaccine dose and were monitored for at least 11 days from the date of vaccination. On day 14 there was a “significant decrease of about 33% in the rate of positive tests for the coronavirus” among those who had been vaccinated. This decrease remained the same between days 15 and 17.

The report has raised concerns, as published results have suggested that the efficacy of the Pfizer vaccine was 52.4% between the first and second dose (spaced 21 days apart), and data assessed by Public Health England indicated it could be as much as 89% protective from day 15 to 21.

The Clalit Research Institute stressed, however, that its results included only people aged 60 and over—whereas Pfizer trials also included younger people—and that the findings have not yet been peer reviewed. Additionally, the Clalit study identified those infected according to laboratory tests of those who chose to be tested, while Pfizer’s studies only referred to the appearance of symptomatic disease.

In the UK, the vaccine policy prioritises getting as many at risk people vaccinated with one dose over ensuring people get two doses within the time specified in clinical trials. While there are data to suggest the chosen 12 week interval between the two doses is effective for the Oxford AstraZeneca vaccine, there are no data to support this interval for the Pfizer vaccine.3

As such, a leading statistician has written to UK health secretary Matt Hancock urging him to investigate the effects of the decision to extend the gap between the first and second dose of the Pfizer BioNTech vaccine.4

On the reports from Israel, UK chief scientific adviser Patrick Vallance, in an interview with Sky News, said, “We know that when you get into real world practice, things are seldom quite as good as clinical trials. I don’t know exactly what data Israel are looking at, but we need to look at this carefully.”

Meanwhile, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine Stephen Evans said, “The UK will soon have its own data showing efficacy after the first dose for the different vaccines currently in use and any policy changes should await more robust data. If, for example, efficacy after one dose was 33% but efficacy after two doses was 60%, the UK policy would still be justified. Similar arguments apply in relation to efficacy against serious disease.”

https://www.bmj.com/content/372/bmj.n217

Johnson & Johnson applies to WHO for emergency use listing of COVID-19 vaccine

 Johnson & Johnson said on Friday it had submitted data to the World Health Organization (WHO) for emergency use listing of its COVID-19 vaccine, which would allow for wider access of the one-dose shot.

J&J said an emergency use listing is a prerequisite for supplying vaccines to the COVAX vaccine program, co-led by WHO, which aims to deliver doses to poor and middle-income countries.

The J&J vaccine is administered in a single dose and can be stored at normal fridge temperatures, a big selling point in countries with relatively weaker healthcare infrastructure.

The vaccine is under review by the U.S. health regulator, and a panel of the Food and Drug Administration’s experts are expected to discuss the vaccine’s emergency use authorization next week.

The vaccine is being rolled out in South Africa, for the first time outside a major clinical trial.

J&J said last month the vaccine was 66% effective in preventing COVID-19 in a large late-stage global trial against multiple variants of the coronavirus. The level of protection of the vaccine varied from 72% in the United States, to 66% in Latin America and 57% in South Africa.

The company said the data delivered to WHO includes results from the late-stage trial.

J&J entered into an agreement in December in support of the COVAX program.

The company and Gavi, which also co-leads COVAX, expect to enter into an advance purchase agreement that would provide up to 500 million doses of the single-dose vaccine to COVAX through 2022, J&J said.

https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-wh/johnson-johnson-submits-emergency-use-listing-to-who-for-covid-19-vaccine-idUSKBN2AJ1DE

Vaccinex Signs 2 Deals Leveraging ActivMAb® Platform

 Partnerships will use Vaccinex’s ActivMAb® platform for viral display of complex antigens to enable antibody discovery

Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced the signing of multi-project deals with two undisclosed prominent pharmaceutical companies. The collaborations will focus on using ActivMAb®, Vaccinex’s antibody discovery and novel viral display platform, for antibody discovery against complex antigens such as GPCRs and ion channels. Financial terms of the deals are undisclosed.

https://finance.yahoo.com/news/vaccinex-announces-signing-two-multi-130000730.html