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By PharmaCompass
2021-09-23
Impressions: 1,927 Article
This week, Phispers brings you more updates on Covid-19 vaccines and booster shots. Pfizer-BioNTech was in the news as the booster dose of the vaccine won FDA’s authorization for the elderly and at risk patients. The jab was also found to be safe and protective in phase 2/3 trials on five to 11 year old children.
Johnson & Johnson has released data that shows its booster shot significantly extends the window of protection from the coronavirus. Data from phase 3 trial of the J&J booster shot shows it is 94 percent effective when given two months after the first dose.
In Brazil, the police raided the offices of Precisa Medcamentos, which had signed a deal to procure 20 million doses of Indian drugmaker Bharat Biotech’s Covid-19 vaccine, known as Covaxin. The contract was later suspended due to charges of corruption and irregularities.
The US will ease tough pandemic-related restrictions and will reopen in November to fully-vaccinated air travelers from 33 countries including China, India, Brazil and most of Europe.
An ex-employee of Mylan has pleaded guilty to an insider trading scheme. He collaborated with a senior manager of the company and traded in securities of Mylan ahead of announcements concerning drug approvals, financial earnings and a merger.
The UK came out with its revised travel advisory. While it okayed Covishield (AstraZeneca-Oxford vaccine manufactured by Serum Institute of India) as a qualified vaccine for travel, it said it has problems with India’s vaccine certification. India, on the other hand, said it won’t buy Pfizer and Moderna’s vaccines, because the domestic output of more affordable and easier-to-store vaccines has increased in the country.
FDA authorizes Pfizer booster dose for elderly, at risk patients; jab found safe for 5-11 year olds
The US Food and Drug Administration (FDA) has authorized a booster dose of the Pfizer-BioNTech Covid-19 vaccine for the elderly (65 years and older), all people at high risk of severe disease, and others who are regularly exposed to the virus.
The change to the vaccine’s emergency use authorization (EUA) will allow boosters for groups such as healthcare workers, teachers and day-care staff, grocery workers and those in homeless shelters or prisons, FDA acting commissioner Janet Woodcock said in a statement.
The booster shot can be administered as soon as this week for millions of people who are now eligible. Some of them had received the second dose of the Pfizer shot at least six months ago.
Last week, an influential FDA advisory committee had rejected a proposal to distribute booster shots of Pfizer and BioNTech’s Covid-19 vaccine to the general public.
A US Centers for Disease Control and Prevention (CDC) advisory panel could vote on the use of a third shot of the Pfizer vaccine on September 23. The CDC’s Advisory Committee on Immunization Practices (ACIP) will weigh which populations would most benefit from a third shot. Last month, the US had authorized extra shots for people with compromised immune systems and, according to CDC, over 2 million people have already received a third shot. Some countries, including Israel and Britain, have rolled out booster campaigns.
Meanwhile, Anthony Fauci, President Joe Biden’s chief medical adviser, has said data needed to determine the advisability of booster shots of Moderna and Johnson & Johnson vaccines is just weeks away. “We recommend that people wait until you get to the point where you fall into the category where it’s recommended,” he told CNN.
Pfizer shots for five to 11 year olds: Results from phase 2/3 clinical trials show that Pfizer-BioNTech’s Covid-19 vaccine induced a robust immune response in five to 11 year old children. The two companies plan to seek regulatory authorization as soon as possible.
Since earlier studies had revealed the possibilities of more side effects, the pediatric study used a lower dose of the vaccine. While adults had received two 30 microgram doses of the vaccine three weeks apart, for children, the dose was lowered to 10 micrograms.
The antibody response in children was roughly comparable to the response in participants aged 16 to 25 years.
“Since July, pediatric cases of Covid-19 have risen by about 240 percent in the US — underscoring the public health need for vaccination,” Pfizer CEO Albert Bourla said in a statement. “These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
According to a Reuters report, regulators could make a decision on whether the shot is safe and effective in younger children within three weeks of the companies submitting a request for authorization.
Brazilian police raids Precisa to probe potential irregularities with Bharat Biotech deal
Last week, the Brazilian federal police raided the offices of Precisa Medicamentos, a Brazil-based pharmaceutical company, in order to investigate the potential irregularities in procuring 20 million doses of Covaxin from Indian drugmaker Bharat Biotech.
The raid was authorized by Brazil’s Supreme Court and follows evidence raised by a Senate inquiry probing the federal government’s plan to purchase Covaxin. The contract was signed in February, but was later suspended.
According to a news report published in The Wire, the parliamentary commission of inquiry (CPI) into the Covaxin deal has entered its final phase. Brazilian senate investigators say they may implicate President Jair Bolsonaro for corruption even as they ramp up efforts to trace a missing agreement between Bharat Biotech and Precisa to find how much money was to be paid to the latter in the US$ 300-million deal.
The raid on Precisa was the first search-and-seize action sought by the commission which has been probing the irregularities in the deal.
US to reopen to fully-vaccinated air travelers from 33 countries in November
The US President Joe Biden has said the country will reopen in November to air travelers from 33 countries including China, India, Brazil and most of Europe who are fully vaccinated against Covid-19. This would ease tough pandemic-related restrictions that were started in early 2020. Only last week, Biden had said it was not the right time to lift any restrictions amid rising Covid-19 cases.
The US had lagged many other countries in lifting travel restrictions that have barred travelers from most of the world. The country will admit fully vaccinated air travelers from the 26 Schengen countries in Europe including France, Germany, Italy, Spain, Switzerland and Greece, as well as Britain, Ireland, China, India, South Africa, Iran and Brazil.
While on the one hand US eased air travel restrictions, on Monday the country extended pandemic-related restrictions at land borders with Canada and Mexico that bar nonessential travel, such as tourism, until October 21.
According to industry trade group — Airlines for America — through late August, international air travel was down 43 percent from pre-pandemic levels.
Ex-Mylan employee pleads guilty to insider trading by collaborating with senior exec
Last week, a former information technology (IT) executive of Mylan pleaded guilty to an insider trading scheme where he had bought and sold stock options on another executive’s advice.
Dayakar Mallu, Mylan’s former vice president of global IT operations, collaborated with an unnamed “senior manager,” the US Securities and Exchange Commission (SEC) said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared the profits.
As a result, Mallu landed more than US$ 8 million in unrealized profits and losses avoided, resulting in net profits and losses avoided of more than US$ 4.2 million, the Department of Justice said. Mallu faces a maximum penalty of 25 years in prison for the conspiracy offense and three years in prison for the tax offense. He is scheduled to be sentenced in January 2022.
Ahead of Mylan’s planned merger with Upjohn, prosecutors allege the Mylan executive tipped off Mallu. The unnamed manager was “involved in integration planning and due diligence for Mylan relating to the transaction with Pfizer,” the complaint said. Mallu bought more than US$ 8.4 million of call options between July 18 and July 23, 2019. With the announcement of the merger on July 29, the value of Mallu’s contracts increased by US$ 2.2 million.
J&J says booster increases effectiveness to 94 percent against moderate to severe Covid-19
There has been much talk about booster shots over the last month or so. After Pfizer, Johnson & Johnson has now released data that shows its booster shot significantly extends the window of protection from the coronavirus.
In a statement, J&J chief scientific officer Paul Stoffels said while its single-dose vaccine remains strongly effective for up to eight months, a booster “further increases protection against Covid-19 and is expected to extend the duration of protection significantly.”
J&J has said it will submit all of its trial data to the FDA for potential recommendation of a booster and approval of a two-dose regimen. The company has also stressed on the durability of its single-shot vaccine as a tool to ease the global pandemic.
Stoffels referred to the phase 3 US trial data of the J&J shot, which shows it is 94 percent effective when given two months after the first dose, and it also boosts antibody levels.
J&J said the booster is 100 percent effective in protecting against severe and critical disease. The side effects of the booster are generally the same those with the initial dose. According to the CDC, 14.8 million Americans have received the J&J vaccine.
UK okays Covishield as qualified vaccine for travel; has problems with India’s vaccine certification
This week, the UK came out with its revised travel advisory that said a traveller will be considered fully vaccinated if they are inoculated with a full dose of the Oxford-AstraZeneca, Pfizer-BioNTech, Moderna, or Janssen vaccines from a relevant public health body in select countries.
Moreover, the UK travel advisory said that Covishield, the coronavirus disease vaccine jointly developed by AstraZeneca and Oxford University and manufactured by the Serum Institute of India (SII) – will qualify as an approved vaccine for travelers visiting Britain from any part of the world from October 4 onwards. Earlier, India had protested the UK’s non-recognition of Covishield and had warned of “reciprocal measures” if the “discriminatory policy” was not amended.
The guidelines provided in the latest advisory suggest that Britain has no problems with the formulation of the Covishield vaccine. However, it does have problems with the vaccine certification provided by India. Due to the vaccine certification issue, Indians vaccinated with two doses of Covishield will still need to quarantine after the arrival.
The UK government has said that Covid-19 vaccine certification from all countries must meet a “minimum criteria” and that it is working with India on a “phased approach” to its international travel norms, an NDTV report said.
India won’t buy Pfizer, Moderna jabs: The Indian government will not buy Covid-19 shots from Pfizer-BioNTech and Moderna since the output of more affordable and easier-to-store vaccines made in India has increased.
This means that the two popular messenger RNA vaccines will not be available in the world’s most populous countries — India and China. Both Pfizer-BioNTech and Moderna have pledged not to sell their vaccines to private parties during the pandemic.
India’s monthly domestic output has trebled since April and will reach 300 million doses in October, a Reuters news report said. India also announced restarting of vaccine exports from October.
The Indian government has also declined to meet American companies’ requests for indemnity over any side-effects from the use of their shots, which are currently made only in the US or Europe.
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