The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.
“Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This vaccine will help protect individuals from serious illness and death from influenza.”
The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.
”The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” said Jesse Goodman, M.D., FDA acting chief scientist.
Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.
Clinical studies under way will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.
As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.
People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.
In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.
For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and -- in children 2 to 6 years old -- fever.
As with any medical product, unexpected or rare serious adverse events may occur. The FDA is working closely with governmental and nongovernmental organizations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention.
A Pune-based biotechnology company Indus Biotech Pvt. Ltd claims it can help the government in its fight against the H1N1 virus—by providing a new antiviral, which is derived from a plant in the human food chain and hence is very low on toxicity, a burden that most synthetic drugs come with.
The claim comes even as governments around the world are continuing to hunt for more weapons in their arsenal to fight the influenza virus, which, historically, is known to surface in mutated forms.
While Indus has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for the compound’s action against HIV, subsequent research at one of the laboratories it works with at the National Taiwan University Hospital in Taipei showed that the compound is very effective against another virus—H1N1.
The company now proposes to develop this drug for influenza and H1N1, both as a drug as well as a prophylactic since it shows promise in preventing the infection.
The Indus team will present the data, which was reviewed by Mint, to the Union health ministry next week and seek an approval road map as India, unlike the US, doesn’t have guidelines for botanical drugs—drugs that are made from plant extracts. “Our science is impeccable and we are open to scrutiny from any agency,” says Sunil Bhaskaran, managing director of Indus.
The start-up has worked for 12 years on developing a new class of drugs for chronic life style, autoimmune and degenerative diseases, and a new drug for infectious diseases could well be a way to cash in on the current flu scare. That isn’t the case, says Bhaskaran: “This is sheer coincidence and serendipity as we don’t work on infectious diseases.”
While testing a compound on asthma, and studying the link between inflammation and autoimmune diseases, Indus came across an interesting mechanism that triggers inflammation. “We were curious and tested our compound on HIV virus two years ago in a high safety lab in Taipei and we found it confirmed our hypothesis,” says Bhaskaran. The influenza virus came next; the H1N1 test followed. Indus claims its compound is effective in Tamiflu-sensitive (strain 676) as well as Tamiflu-resistant (strain 6706) swine flu.
After completing its patent filing on 11 August, Indus submitted its H1N1 data to the health ministries of Cambodia and the Philippines, which are currently evaluating it for placing supply orders. Experts say H1N1, like other influenza viruses, mutates fast, so attacking it with just one drug—as is the case today—is not a good strategy. “Combination therapy, as is seen in HIV, is always advisable in fights against virus. That’s why you see that countries that use flu shots for the seasonal virus, develop it every year, depending on the virulent strain,” says Sunit Kumar Singh, a scientist at the Centre for Cellular and Molecular Biology in Hyderabad, who works on infectious diseases and immunobiology.
Founded in 1997 with a small round of angel fund of $600,000 (Rs2.9 crore today), Indus got a monetary infusion when the private equity (PE) arm of Kotak Mahindra Bank Ltd invested about $6 million in it in late 2007. The cornerstone of this biotech firm is a proprietary technology that allows it to isolate new molecules from plant extracts, and keep them in stable conditions as such molecules tend to degrade or change composition once outside the plant body.
One of the challenges before the drug discovery companies that do bioprospecting is their inability to produce a standardized product, says Rajan R. Srinivasan, executive director of Indus. In the absence of such a process, called chemistry and manufacturing control by FDA, plant-derived products remain in the nutritional category and never reach the prescription drug level.
Perhaps, because of this, since June 2004 when FDA first released its botanical drug guidelines, the drug regulator has only approved one—a green tea extract-based medicine for topical application in vaginal warts, says Srinivasan. His team was pleasantly surprised when FDA assigned them a pre-IND number, which is usually given after the final approval.
Indus has a calculated strategy: the starting point, always, is food chain raw materials with well-known medicinal value, so that toxicity risk is minimal. It conducts proof of concept studies in humans at a very early stage, even though they are not mandatory in standard IND application. “By design, we have orphan positioning for most drug candidates with respect to the US FDA, which allows for shorter approval time with smaller studies,” says Srinivasan. An orphan drug, according to FDA, is one that addresses a disease affecting less than 200,000 people in the US and hence, isn’t of interest to most pharmaceutical firms.
Indus has been exporting finished formulations as prescription herbal medicines through pharmaceutical marketing partners in West Asia and South-East Asian countries.
Nitin Deshmukh, head of PE at Kotak Mahindra, calls it “the most promising botanical drug company out of India”.
“That’s why we are filing INDs in the US and we’ll take these molecules to their logical conclusion in the US market,” he added.
Drug firm Strides Acrolab on Tuesday said it is in a position to supply Oseltamivir Capsules, the only available medicine against Influenza A HINI virus (Swine Flu), to meet the demand both from domestic and overseas market.
"Strides is fully geared to meet significant supply of the product for domestic and international market," Strides Acrolab Ltd CEO India Operations said in a statement.
Oseltamivir Capsules are the generic version of Roche''s patented drug ''Tamiflu''. Strides'' generic Oseltamivir is manufactured in US FDA approved manufacturing facility in Bangalore and the company has conducted necessary bioequivalence studies and established bioequivalence of its product with Tamiflu, the company said.
Source - Economic times
NEW DELHI: The Union Health Ministry said 82 fresh swine flu cases were reported from across the country on Sunday, with the maximum of 34 coming from Pune. The break-up of those tested positive to the A(H1N1) virus is: Delhi (13), Mumbai (12), Chennai (7), Goa (4), Vadodara (3), Kozhikode (2), Hyderabad (2), Gurgaon (2), Thiruvananthapuram (1), Sirsa in Haryana (1) and Thrissur (1).
All the 34 cases in Pune are indigenous ones, mostly schoolchildren. In Mumbai, 11 are indigenous cases, while the 12th patient is an 8-year-old boy, who recently arrived from Europe.
In Delhi, of the 13 cases, 12 came through contact, while one patient travelled from Singapore. In Chennai, all seven are indigenous cases. Officials said that so far 4,084 persons had been tested for the virus of which 864 were positive. While 633 persons had been identified through entry screening, 803 through ‘contact tracing’ and the rest were ‘self-reported’ cases. Of the 864 positive cases, 523 had been discharged.