Sanofi/GSK announce delay in COVID-19 vaccine project

France’s Sanofi and Britain’s GSK said on Dec. 11, 2020 that their Covid-19 vaccines will not be ready until the end of 2021, after interim results showed a low immune response in older adults. (AFP)
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Updated 11 December 2020
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Sanofi/GSK announce delay in COVID-19 vaccine project

  • The two companies said they planned to launch another study next year, hoping to come up with a more effective vaccine by the end of 2021
  • This week, Britain started deploying a vaccine that uses a breakthrough mRNA technology developed by Pfizer and BioNTech

PARIS: An experimental COVID-19 vaccine developed by Sanofi and Britain’s GlaxoSmithKline showed an insufficient immune response in clinical trial results, the French drugmaker said on Friday, a blow to efforts to fight the pandemic.
The two companies said they planned to launch another study next year, hoping to come up with a more effective vaccine by the end of 2021.
The news comes as a disappointment for a crop of vaccines under development that rely on more conventional proven designs as the shot developed by Pfizer and BioNTech using breakthrough technology gets rolled out across Britain.
Friday’s results, Sanofi said, showed “an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.”
Phase III studies were expected to start this month.
Sanofi said it would launch a phase 2b study in February of next year instead after a recent challenge study in non-human primates performed with an improved antigen formulation demonstrated better effects.
“The study will include a proposed comparison with an authorized COVID-19 vaccine,” the company said.
“If data are positive, a global Phase III study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.”
The two companies said they had “updated governments and the European Commission where a contractual commitment to purchase the vaccine has been made.”
The Sanofi-GSK vaccine uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the vaccine, made by GSK.
The companies would have been be 14th player to embark on Phase III studies on potential vaccines as governments struggle to tame the pandemic that has killed more than 1.5 million people, according to World Health Organization records.
The Phase I/II study tested the safety, tolerability and immune response of the vaccine in 440 healthy adults across 11 investigational sites in the United States.
The partners are not the first in the race, but they believe their respective experience in the fields of vaccines is an advantage.
This week, Britain started deploying a vaccine that uses a breakthrough mRNA technology developed by Pfizer and BioNTech, jumping ahead of the rest of the world in the race. Canada gave the greenlight for the shot, too.
The data comes as the US regulator considers the Pfizer-BioNTech vaccine for approval. Rival developers AstraZeneca Plc and Moderna have also reported late stage data that shows their shots are effective at preventing the virus.
The French group is also working on another vaccine candidate to prevent COVID-19 with US company Translate Bio which will rely on a different technology called mRNA, similar to the developed by Pfizer and Moderna.
Phase I trials for this vaccine are expected to start this month.
Sanofi and GSK have scaled up manufacturing in order to be ready to produce up to one billion doses of their vaccine in 2021 and have secured a handful of contracts including deals with the European Union, the United States, Canada and Britain.
GSK is contributing adjuvants to two other COVID-19 vaccines projects, one with Medicago of Canada and the other with China’s Clover Biopharmaceuticals.


Privacy activists call on California to remove covert license plate readers

Updated 4 sec ago
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Privacy activists call on California to remove covert license plate readers

  • Groups believe gadgets feed data into a controversial US Border Patrol predictive domestic intelligence program
  • An algorithm flags vehicles deemed suspicious based on where they came from, where they were going and which route they took
More than two dozen privacy and advocacy organizations are calling on California Gov. Gavin Newsom to remove a network of covert license plate readers deployed across Southern California that the groups believe feed data into a controversial US Border Patrol predictive domestic intelligence program that scans the country’s roadways for suspicious travel patterns.
“We ask that your administration investigate and release the relevant permits, revoke them, and initiate the removal of these devices,” read the letter sent Tuesday by the Electronic Frontier Foundation, Imperial Valley Equity and Justice and other nonprofits.
An Associated Press investigation published in November revealed that the US Border Patrol, an agency under US Customs and Border Protection, had hidden license plate readers in ordinary traffic safety equipment. The data collected by the Border Patrol plate readers was then fed into a predictive intelligence program monitoring millions of American drivers nationwide to identify and detain people whose travel patterns it deems suspicious.
AP obtained land use permits from Arizona showing that the Border Patrol went to great lengths to conceal its surveillance equipment in that state, camouflaging it by placing it inside orange and yellow construction barrels dotting highways.
The letter said the groups’ researchers have identified a similar network of devices in California, finding about 40 license plate readers in San Diego and Imperial counties, both of which border Mexico. More than two dozen of the plate readers identified by the groups were hidden in construction barrels.
They could not determine of the ownership of every device, but the groups said in the letter that they obtained some permits from the California Department of Transportation, showing both the Border Patrol and Drug Enforcement Administration had applied for permission to place readers along state highways. DEA shares its license plate reader data with Border Patrol, documents show.
The letter cited the AP’s reporting, which found that Border Patrol uses a network of cameras to scan and record vehicle license plate information. An algorithm flags vehicles deemed suspicious based on where they came from, where they were going and which route they took. Agents appeared to be looking for vehicles making short trips to the border region, claiming that such travel is indicative of potential drug or human smuggling.
Federal agents in turn sometimes refer drivers they deem suspicious to local law enforcement who make a traffic stop citing a reason like speeding or lane change violations. Drivers often have no idea they have been caught up in a predictive intelligence program being run by a federal agency.
The AP identified at least two cases in which California residents appeared to have been caught up in the Border Patrol’s surveillance of domestic travel patterns. In one 2024 incident described in court documents, a Border Patrol agent pulled over the driver of a Nissan Altima based in part on vehicle travel data showing that it took the driver six hours to travel the approximately 50 miles between the US-Mexican border and Oceanside, California, where the agent had been on patrol.
“This type of delay in travel after crossing the International Border from Mexico is a common tactic used by persons involved in illicit smuggling,” the agent wrote in a court document.
In another case, Border Patrol agents said in a court document in 2023 they detained a woman at an internal checkpoint because she had traveled a circuitous route between Los Angeles and Phoenix. In both cases, law enforcement accused the drivers of smuggling immigrants in the country unlawfully and were seeking to seize their property or charge them with a crime.
The intelligence program, which has existed under administrations of both parties, has drawn scrutiny from lawmakers since the AP revealed its existence last year.
A spokesperson for the California Department of Transportation said state law prioritizes public safety and privacy.
The office of Newsom, a Democrat, did not immediately respond to requests for comment.
Courts have generally upheld license plate reader collection on public roads but have curtailed warrantless government access to other kinds of persistent tracking data that might reveal sensitive details about people’s movements, such as GPS devices or cellphone location data. Some scholars and civil libertarians argues that large-scale collection systems like plate readers might be unconstitutional under the Fourth Amendment.
“Increasingly, courts have recognized that the use of surveillance technologies can violate the Fourth Amendment’s protections against unreasonable searches and seizures. Although this area of law is still developing, the use of LPRs and predictive algorithms to track and flag individuals’ movements represents the type of sweeping surveillance that should raise constitutional concerns,” the organizations wrote.
CBP did not immediately respond to a request for comment, but previously said the agency uses plate readers to help identify threats and disrupt criminal networks and their use of the technology is “governed by a stringent, multi-layered policy framework, as well as federal law and constitutional protections, to ensure the technology is applied responsibly and for clearly defined security purposes.”
The DEA said in a statement that the agency does not publicly discuss its investigative tools and techniques.