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EMA hit by cyberattack that accesses vaccine data; allergic reaction to Pfizer vaccine reported in UK
This week, Phispers brings you more news from the US, where the drug industry has filed two lawsuits against the Trump administration for rushing in new rules pertaining to drug pricing. The US Food and Drug Administration released documents on the efficacy of the Pfizer-BioNTech vaccine. Pfizer told the Trump administration that it can’t provide substantial additional doses of its coronavirus vaccine until late June or July because other countries have rushed to buy up most of its supply. Trump, on the other hand, signed an executive order aimed at granting Americans priority access to vaccines. And President-elect Joe Biden selected a new CDC chief, and a new secretary for HHS.
In the UK, the medicines regulator has issued a precautionary advice on the Pfizer-BioNTech vaccine, advising people with a history of significant allergic reactions to not take the shot. This step was taken as two NHS workers suffered an allergic reaction after taking the vaccine. Days after IBM uncovered a global phishing campaign targeting the Covid-19 vaccine cold chain, the EMA said it has been hit by a cyberattack. And a UN panel removed marijuana from the list of most risky narcotics, paving the way for an expansion in research on marijuana and its medical use.
EMA hit by cyberattack days after IBM uncovers phishing campaign targeting vaccine cold chain
The European Medicines Agency (EMA) has been hit by a cyberattack days after IBM’s cybersecurity division said a series of cyberattacks is underway that targets companies and government bodies that will be distributing Covid-19 vaccines across the world.
While the EMA did not give out any details, BioNTech issued a statement that said documents related to its Covid-19 vaccine developed in partnership with Pfizer were “unlawfully accessed.”
“It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed. At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law. EMA has assured us that the cyber attack will have no impact on the timeline for its review,” BioNTech stated in a statement.
In a blog post published last week, IBM said it had uncovered “a global phishing campaign” focused on organizations associated with the Covid-19 “cold chain”. IBM’s cybersecurity unit said it had detected an advanced group of hackers working on gathering information about different aspects of the cold chain, using cleverly drafted emails sent in the name of an executive with Haier Biomedical, a Chinese cold chain provider that specializes in vaccine transport.
Targets included companies involved in the manufacture of solar panels, which are used to power vaccine refrigerators in warm countries, and petrochemical products that could be used to derive dry ice.
The US Department of Homeland Security has issued its own warning on this threat. Both the IBM researchers and the Department of Homeland Security said the attacks appear intended to steal the network log-in credentials of corporate executives and officials at global organizations involved in the refrigeration process necessary to protect vaccine doses.
MHRA tells people with allergies to avoid Pfizer’s jab after two NHS workers suffer reactions
The UK began its mass vaccination program this week. And on the first day of the program, two National Health Service (NHS) workers, who received the Pfizer-BioNTech vaccine, suffered an allergic reaction. After the incident, the UK medicines regulator — Medicines and Healthcare products Regulatory Agency (MHRA) — issued precautionary advice to NHS trusts that anyone who has a history of “significant” allergic reactions should not receive the vaccine. This includes reactions to medicines, food, or vaccines.
Both the NHS workers have a history of serious allergies and carry adrenaline pens with them. They had a reaction shortly after being given the vaccine but have recovered after treatment. They reportedly had an anaphylactoid reaction, an allergic reaction that tends to involve a skin rash, breathlessness and sometimes a drop in blood pressure.
The MHRA has said the advice to healthcare professionals is “precautionary”, and that the reaction was not a side-effect observed in trials.
The MHRA has also mandated that resuscitation facilities be available at all times for all vaccinations. “Vaccination should only be carried out in facilities where resuscitation measures are available,” the regulator has said.
UN panel votes to remove marijuana from list of most risky narcotics
Last week, a United Nations commission voted to remove marijuana for medical use from a list of the world’s most risky narcotics. This is being seen as a long-delayed decision that could clear the way for an expansion of research on marijuana for medical use.
The vote came from the UN Commission for Narcotic Drugs (CND), which is based in Vienna. It considered a series of recommendations from the World Health Organization (WHO) on reclassifying cannabis and its derivatives. But attention centered on a key recommendation to remove cannabis from Schedule IV of the 1961 Single Convention on Narcotic Drugs — where it was listed alongside dangerous and highly addictive opioids like heroin. Cannabis has been on this list for 59 years.
In recent years, marijuana for medical use has seen an explosion of sorts, with several products containing cannabis derivatives like cannabidiol or CBD, a nonintoxicating compound, flooding the market. Research has suggested that CBD can protect the nervous system and provide relief from seizures, pain, anxiety, and inflammation. According to estimates, the CBD industry in the US alone could be worth US$ 16 billion by 2025.
Experts say the vote will have no immediate impact on loosening international controls because governments will still have jurisdiction over how to classify cannabis. But many countries look to global conventions for guidance. At present, over 50 nations have adopted medicinal cannabis programs.
FDA publishes Pfizer-BioNTech’s vaccine data before review meet, Canada approves it
While the UK rolled out its mass vaccination program, the US Food and Drug Administration (FDA) released documents of the Pfizer-BioNTech vaccine and said that it raised no new issues about its safety or efficacy. The documents were released ahead of the December 10 meeting of outside experts to the FDA who will discuss whether to recommend the Pfizer shot for people aged 16 and older.
In the documents, the FDA staff has said that the vaccine’s efficacy and safety data met its expectations for emergency use authorization (EUA). Pfizer’s CEO Albert Bourla has said he expects a “very intense” meeting with a US vaccine advisory panel. “I think they will vote ‘yes’ given the strength of the data,” Bourla said.
Last month, Pfizer and BioNTech had said their vaccine’s two-dose regimen was 95 percent effective against Covid-19 and had no major safety issues. It then applied to the FDA for an EUA.
Canada approves Pfizer’s shot: Days ahead of the US granting an EUA to Pfizer-BioNTech’s Covid-19 vaccine, Canada’s health regulator went ahead and approved it on December 9. The vaccine has already been authorized for use by the UK and Bahrain. Health Canada said the terms of the approval require the manufacturer to continue providing information on the vaccine. Canada is likely to receive 249,000 doses this month, and vaccinations are likely to start next week.
Pfizer tells US it can’t provide more doses until late-June: Pfizer has told the Trump administration it cannot provide substantial additional doses of its coronavirus vaccine until late June or July because other countries have rushed to buy up most of its supply.
That means the US government may not be able to ramp up vaccination programs as rapidly as it had expected. However, Trump administration officials denied there would be availability issues in the second quarter, citing that there are other vaccines in the pipeline.
The US government had a different type of contract with Pfizer as compared to its contract with other companies involved with Operation Warp Speed. Pfizer was the only company that did not take government money for research and development.
Meanwhile, US President Donald Trump has signed an executive order aimed at granting Americans priority access to vaccines. The order tells pharmaceutical companies to prioritize America, though it’s unclear whether the order can actually come into effect.
Astra publishes additional data: AstraZeneca
has published additional vaccine data from four clinical trials in The
Lancet, a weekly peer-reviewed medical journal. The data indicates that the vaccine has moderate efficacy in preventing symptomatic illness and may significantly reduce incidents of hospitalization due to Covid-19.
Topline data on the AstraZeneca vaccine from a Phase 3 trial was released in November. The data released this week pooled data from Phase 1/2 and Phase 2/3 trials in the United Kingdom, a Phase 3 trial in Brazil and a Phase 1/2 trial in South Africa. Most of the participants in the trials were adults aged 18 to 55. Therefore, the evidence for efficacy of this vaccine in older adults is limited.
The paper did not attempt to estimate the efficacy of the vaccine in the population above the age of 55 years, saying more work would be done to look at the question. The efficacy data was based on 11,636 participants.
Drug industry trade groups file two lawsuits against Trump’s drug pricing rules
After the Trump administration rushed in new rules last month, pharmaceutical industry trade groups have filed two lawsuits against it. The lawsuits against the new rules aimed at lowering drug prices were filed in federal courts in Maryland and California by drug industry trade group — Pharmaceutical Research and Manufacturers of America (PhRMA) — and a group of biotechnology industry trade organizations, including Biotechnology Innovation Organization (BIO).
Both suits claim, among other things, that the administration did not follow the appropriate process by failing to collect feedback from stakeholders before announcing the new rule.
Since he lost the presidential election, US President Donald Trump has been issuing rules in diverse areas such as energy, healthcare, and immigration. Last month, Trump administration had finalized a rule that would tie payments for some drugs made by Medicare to the lowest price paid by certain other countries. Known as the most favored nation (MFN) rule, the administration had said it could save taxpayers and patients US$ 85 billion over seven years. The MFN rule would come into effect on January 1, 2021,
In a statement, PhRMA, the Association of Community Cancer Centers (ACCC), the Global Colon Cancer Association (GCCA) and National Infusion Center Association (NICA) said the MFN Interim Final Rule exceeds the statutory authority provided to the Centers for Medicare and Medicaid Services, raises serious constitutional questions and fails to follow required rule-making procedures.
PhRMA Executive Vice President and General Counsel James C. Stansel stated: “By proceeding with an interim final rule, the administration has also deprived the American public of their right to provide input on these drastic changes before they are implemented.” PhRMA has requested the court to halt the rule before it can be implemented.
President-elect Joe Biden announces new CDC chief, new secretary for HHS
President-elect Joe Biden made his picks for two key healthcare bodies — the Centers for Disease Control and Prevention (CDC) and the US Department of Health and Human Services (HHS). Biden has selected Rochelle Walensky, the chief of infectious diseases at Massachusetts General Hospital, to run the CDC, and Xavier Becerra as his Health and Human Services secretary. Becerra is currently California’s Attorney General, and will replace Alex Azar.
Walensky is also a professor of medicine at the Harvard Medical School and an expert on AIDS and HIV. She will be tasked with rebuilding the CDC, which has been sidelined by the Trump administration. Walensky will replace Robert Redfield, who assumed the role of director in March 2018. She will play a key role in helping the Biden administration curtail the pandemic.
Similarly, Becerra will also have a long list of priorities in tackling the pandemic, including expanding testing, improving access to personal protective equipment and distributing a Covid-19 vaccine. He will also be responsible for another top goal of the Biden administration - strengthening and building up the Affordable Care Act.
On Friday, for the first time the CDC recommended that people wear masks at all times when they’re not at home. This guidance echoes Biden’s call for a nationwide mask mandate.
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