Virus World

Nov 30 (Reuters) - Pfizer (PFE.N) has been sued by Texas Attorney General Ken Paxton, who on Thursday accused the drugmaker of misrepresenting the efficacy of its widely-used COVID-19 vaccine. In a complaint filed in a Lubbock County state court, Paxton said it was misleading for Pfizer to claim its vaccine was 95% effective because it offered a "relative risk reduction" for people to who took it. Paxton said the claim was based on only two months of clinical trial data, and vaccine recipients' "absolute risk reduction" showed that the vaccine was just 0.85% effective. He also said the pandemic got worse even after people started taking the vaccine, developed by Pfizer and its German partner BioNTech (22UAy.DE). "Pfizer intentionally misrepresented the efficacy of its COVID-19 vaccine and censored persons who threatened to disseminate the truth in order to facilitate fast adoption of the product and expand its commercial opportunity," the complaint said. The lawsuit seeks to stop New York-based Pfizer from making alleged false claims and silencing "truthful speech" about its vaccine, and more than $10 million in fines for violating a Texas law protecting consumers from deceptive marketing. Pfizer said more than 1.5 billion of people have received its vaccine. The drugmaker has reported more than $74 billion of revenue in 2021 and 2022 related to COVID-19 immunizations.

In a statement, Pfizer said its representations about its vaccine have been "accurate and science-based," and that it believed Paxton's lawsuit had no merit. Pfizer also said its vaccine has "demonstrated a favorable safety profile in all age groups, and helped protect against severe COVID-19 outcomes, including hospitalization and death." Infectious disease experts have said relative risk reduction is a more meaningful way to judge a vaccine's efficacy than absolute risk reduction. Relative risk shows how well a vaccine protects recipients relative to a study's control group. Paxton, a Republican, has criticized Biden administration efforts to fight the pandemic. Earlier this year, he began probing whether Pfizer, Moderna (MRNA.O) and Johnson & Johnson (JNJ.N) misrepresented their vaccines' efficacy, to examine the "scientific and ethical basis" for public health decisions addressing COVID-19. "Pfizer did not tell the truth about their COVID-19 vaccines," Paxton said in a statement. "We are pursuing justice for the people of Texas, many of whom were coerced by tyrannical vaccine mandates to take a defective product sold by lies." The lawsuit is Paxton's second against Pfizer in November. In a case unsealed on Nov. 21, Paxton accused Pfizer and a supplier of manipulating quality control tests, resulting in the distribution of ineffective drugs to treat attention deficit hyperactivity disorder in children. The status of the probe into Moderna and Johnson & Johnson was not immediately clear. Paxton's office did not immediately respond to requests for comment. Reporting by Jonathan Stempel in New York; Additional reporting by Caroline Humer; Editing by Chizu Nomiyama and Daniel Wallis

Daegu, the city at the epicentre of South Korea‘s coronavirus outbreak, has filed a civil damages suit against a church that has been linked to over 5,200 of the country’s cases. Widespread infections among members of the Shincheonji Church of Jesus in February and March made South Korea the first country to have a major outbreak outside China. The city now is seeking 100bn won (£66m) in damages from the church for allegedly ignoring the city’s quarantine measures and allowing the disease to spread among its members. The church has insisted it fully complied with government efforts. At least 5,213 of the South Korea's total 12,484 Covid-19 cases have been linked to the church, according to the Korea Centres for Disease Control and Prevention.

Authorities had previously filed a complaint against the church, accusing it of refusing to submit a full list of members and facilities and not cooperating with city health efforts. The church’s founder, Lee Man-hee, has advised members who recovered from the virus to donate their blood plasma for coronavirus research. Around 4,000 recovered Covid-19 patients from the religious group have reportedly agreed to donate their plasma as a way to express gratitude to the government and medical staff. South Korea health officials have said that, in the absence of other treatments or vaccines, plasma therapy may be a way to lower the death rate, especially in critical patients. At least 17 South Koreans have received the experimental therapy, which involves using plasma from recovered patients with antibodies to the virus, enabling the body to defend against the disease. South Korea has reported 281 deaths from Covid-19.

The European Commission said on Monday it had launched legal action against AstraZeneca (AZN.L) for not respecting its contract for the supply of COVID-19 vaccines and for not having a "reliable" plan to ensure timely deliveries. AstraZeneca (AZN.L) said in response that the legal action by the EU was without merit and pledged to defend itself strongly in court. Under the contract, the Anglo-Swedish company had committed to making its "best reasonable efforts" to deliver 180 million vaccine doses to the EU in the second quarter of this year, for a total of 300 million in the period from December to June. But AstraZeneca said in a statement on March 12 it would aim to deliver only one-third of that by the end of June, of which about 70 million would be in the second quarter. A week after that, the Commission sent a legal letter to the company in the first step of a formal procedure to resolve disputes. read more AstraZeneca's delays have contributed towards hampering the bloc's vaccination drive, as the vaccine developed by Oxford University was initially supposed to be the main one in an EU rollout in the first half of this year. After repeated cuts in supplies, the bloc changed its plans and now relies mostly on the Pfizer-BioNTech (PFE.N), (22UAy.DE) vaccine. "The Commission has started last Friday a legal action against AstraZeneca," the EU spokesman told a news conference, noting all 27 EU states backed the move. "Some terms of the contract have not been respected and the company has not been in a position to come up with a reliable strategy to ensure timely delivery of doses," the spokesman said, explaining what triggered the move.

"AstraZeneca has fully complied with the Advance Purchase Agreement with the European Commission and will strongly defend itself in court. We believe any litigation is without merit and we welcome this opportunity to resolve this dispute as soon as possible," AstraZeneca said. Under the contract, the case will need to be resolved by Belgian courts. "We want to make sure there is a speedy delivery of a sufficient number of doses that European citizens are entitled to and which have been promised on the basis of the contract," the spokesman said.  EU officials confirmed the purpose of the legal action was to ensure more supplies than what the company has said it would aim to deliver. The move follows months of rows with the company over supply issues and amid concerns over the efficacy and safety of the vaccine. Still, while the shot has been linked to very rare cases of blood clots, the EU drugs regulator has recommended its use to contain the spread of COVID-19. "We had to send a message to (Pascal) Soriot," an EU official said, referring to AstraZeneca's chief executive. Germany, France and Hungary were among EU states that were initially reticent to sue the company, mostly on the grounds that the move might not speed up deliveries, diplomats said, but eventually they supported it. After the announcement of the legal action, AstraZeneca said it was in the process of delivering nearly 50 million doses by the end of April, a goal which is in line with the revised-down target of supplying only 100 million shots by the end of the quarter. The EU wants AstraZeneca to deliver as many as possible of the promised 300 million doses, but would settle for 130 million shots by the end of June, one EU source familiar with the discussions told Reuters, adding the EU had launched an urgent legal procedure and was invoking financial penalties in case of non-compliance. In a further sign of its irritation towards the company, it has already forgone another 100 million shots that it had an option to buy under the contract signed in August. The spat with AstraZeneca has also stoked a dispute over supplies with former EU member Britain. AstraZeneca said it was prevented from exporting doses from UK factories to make up for some of the shortfalls in the EU, EU officials have said. Now the EU is opposing the export of AstraZeneca shots to Britain from a factory in the Netherlands.